Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT02709889
Collaborator
(none)
200
30
1
35.1
6.7
0.2
Study Details
Study Description
Brief Summary
The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
Actual Study Start Date
:
Sep 23, 2016
Actual Primary Completion Date
:
Aug 27, 2019
Actual Study Completion Date
:
Aug 27, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rovalpituzumab Tesirine Rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
Drug: Rovalpituzumab tesirine
Other Names:
Drug: Dexamethasone
Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).
|
Outcome Measures
Primary Outcome Measures
- Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups [From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).]
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
Secondary Outcome Measures
- Objective Response Rate (ORR) [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.]
ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Clinical Benefit Rate (CBR) [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.]
CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol).
- Duration of Response (DOR) [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.]
DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
- Progression Free Survival (PFS) [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.]
PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
- Overall Survival (OS) [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.]
Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates.
- Serum Concentrations of Rovalpituzumab Tesirine Over Time [Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose]
- Number of Participants With Anti-therapeutic Antibodies (ATA) [Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).]
Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
-
Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
-
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
-
Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Minimum life expectancy of at least 12 weeks
-
Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
-
Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
-
Adequate hematologic and organ function as confirmed by laboratory values
-
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
-
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
-
Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 [PD-1], anti-programmed death-ligand 1 [PD-L1], or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
- Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Exclusion Criteria:
-
Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
-
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
-
Recent or ongoing serious infection, including:
-
Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version [NCI CTCAE] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
-
Known seropositivity for or active infection by human immunodeficiency virus (HIV).
-
Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
-
Women who are pregnant or breastfeeding
-
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
-
History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear.
-
Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner MD Anderson Cancer Ctr /ID# 155424 | Gilbert | Arizona | United States | 85234 |
| 2 | Mayo Clinic - Scottsdale /ID# 155419 | Scottsdale | Arizona | United States | 85259 |
| 3 | University of California, Los Angeles /ID# 155429 | Los Angeles | California | United States | 90095 |
| 4 | Univ California, San Francisco /ID# 155409 | San Francisco | California | United States | 94143-2204 |
| 5 | Cedars-Sinai Medical Center - West Hollywood /ID# 155428 | West Hollywood | California | United States | 90048 |
| 6 | Univ of Colorado Cancer Center /ID# 155415 | Aurora | Colorado | United States | 80045 |
| 7 | Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420 | Denver | Colorado | United States | 80218 |
| 8 | University of Florida - Archer /ID# 155414 | Gainesville | Florida | United States | 32610 |
| 9 | Moffitt Cancer Center /ID# 170220 | Tampa | Florida | United States | 33612-9416 |
| 10 | Emory University Hospital /ID# 155417 | Atlanta | Georgia | United States | 30322 |
| 11 | University of Kentucky Chandler Medical Center /ID# 155423 | Lexington | Kentucky | United States | 40536 |
| 12 | Johns Hopkins University /ID# 155412 | Baltimore | Maryland | United States | 21287 |
| 13 | Massachusetts General Hospital /ID# 155411 | Boston | Massachusetts | United States | 02114 |
| 14 | Dana-Farber Cancer Institute /ID# 171044 | Boston | Massachusetts | United States | 02215 |
| 15 | Mayo Clinic - Rochester /ID# 155416 | Rochester | Minnesota | United States | 55905-0001 |
| 16 | Washington University-School of Medicine /ID# 155425 | Saint Louis | Missouri | United States | 63110 |
| 17 | Rutgers Cancer Institute of NJ /ID# 162010 | New Brunswick | New Jersey | United States | 08903 |
| 18 | University of New Mexico /ID# 205054 | Albuquerque | New Mexico | United States | 87102 |
| 19 | Roswell Park Comprehensive Cancer Center /ID# 162015 | Buffalo | New York | United States | 14263 |
| 20 | Weill Cornell Medical College /ID# 155418 | New York | New York | United States | 10021 |
| 21 | Duke University Medical Center /ID# 155421 | Durham | North Carolina | United States | 27710-3000 |
| 22 | Univ Hosp Cleveland /ID# 155410 | Cleveland | Ohio | United States | 44106 |
| 23 | Oregon Health and Science University /ID# 162011 | Portland | Oregon | United States | 97239 |
| 24 | Greenville Hospital System /ID# 155427 | Greenville | South Carolina | United States | 29605 |
| 25 | Mary Crowley Cancer Research /ID# 162014 | Dallas | Texas | United States | 75230 |
| 26 | Texas Oncology - Forth Worth /ID# 162045 | Fort Worth | Texas | United States | 76104-2150 |
| 27 | University of Texas MD Anderson Cancer Center /ID# 155413 | Houston | Texas | United States | 77030 |
| 28 | University of Utah /ID# 155426 | Salt Lake City | Utah | United States | 84112-5500 |
| 29 | Virginia Cancer Specialists /ID# 162006 | Fairfax | Virginia | United States | 22031 |
| 30 | Northwest Cancer Specialists, P.C. /ID# 155431 | Vancouver | Washington | United States | 98684 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT02709889
Other Study ID Numbers:
- SCRX001-006
First Posted:
Mar 16, 2016
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants were enrolled into a standard 3+3 dose-escalation study within disease-specific cohorts in Part A, and then participants were enrolled into a disease-specific expansion cohort in Part B based on the maximum tolerated dose determined in Part A. |
| Arm/Group Title | Part A: Rovalpituzumab Tesirine 0.2 mg/kg | Part A: Rovalpituzumab Tesirine 0.3 mg/kg | Part A: Rovalpituzumab Tesirine 0.4 mg/kg | Part B: Rovalpituzumab Tesirine 0.3 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Period Title: Overall Study | ||||
| STARTED | 43 | 57 | 12 | 88 |
| Large Cell Neuroendocrine Carcinoma(NEC) | 3 | 4 | 2 | 4 |
| Neuroendocrine Prostate Cancer | 4 | 7 | 3 | 7 |
| Gastroenteropancreatic NEC | 6 | 5 | 2 | 23 |
| Other NEC | 11 | 12 | 1 | 7 |
| Malignant Melanoma | 3 | 6 | 0 | 11 |
| Medullary Thyroid Cancer | 3 | 3 | 0 | 7 |
| Glioblastoma | 4 | 4 | 1 | 14 |
| Other Solid Tumors | 9 | 16 | 3 | 15 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 43 | 57 | 12 | 88 |
Baseline Characteristics
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Total of all reporting groups |
| Overall Participants | 13 | 21 | 36 | 31 | 20 | 13 | 23 | 43 | 200 |
| Age, Customized (Count of Participants) | |||||||||
| < 65 years old |
7
53.8%
|
7
33.3%
|
25
69.4%
|
19
61.3%
|
11
55%
|
11
84.6%
|
17
73.9%
|
23
53.5%
|
120
60%
|
| >= 65 years old |
6
46.2%
|
14
66.7%
|
11
30.6%
|
12
38.7%
|
9
45%
|
2
15.4%
|
6
26.1%
|
20
46.5%
|
80
40%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
5
38.5%
|
0
0%
|
13
36.1%
|
17
54.8%
|
10
50%
|
5
38.5%
|
4
17.4%
|
20
46.5%
|
74
37%
|
| Male |
8
61.5%
|
21
100%
|
23
63.9%
|
14
45.2%
|
10
50%
|
8
61.5%
|
19
82.6%
|
23
53.5%
|
126
63%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||||
| White |
11
84.6%
|
17
81%
|
32
88.9%
|
25
80.6%
|
20
100%
|
10
76.9%
|
20
87%
|
40
93%
|
175
87.5%
|
| Black or African American |
0
0%
|
3
14.3%
|
3
8.3%
|
2
6.5%
|
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
9
4.5%
|
| Asian |
2
15.4%
|
0
0%
|
1
2.8%
|
2
6.5%
|
0
0%
|
1
7.7%
|
1
4.3%
|
0
0%
|
7
3.5%
|
| Other, Not Specified |
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
0
0%
|
1
7.7%
|
0
0%
|
1
2.3%
|
3
1.5%
|
| Not Reported |
0
0%
|
0
0%
|
0
0%
|
2
6.5%
|
0
0%
|
1
7.7%
|
2
8.7%
|
1
2.3%
|
6
3%
|
Outcome Measures
| Title | Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups |
|---|---|
| Description | The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment. |
| Time Frame | From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set: participants who received any amount of study drug. Presented by NEC/Non-NEC groups, inclusive of participants in parts A and B. |
| Arm/Group Title | NEC: 0.2 mg/kg | NEC: 0.3 mg/kg | NEC: 0.4 mg/kg | NEC: Any Dose | Non-NEC: 0.2 mg/kg | Non-NEC: 0.3 mg/kg | Non-NEC: 0.4 mg/kg | Non-NEC: Any Dose |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin, neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM), medullary thyroid cancer (MTC), glioblastoma (GBM), or other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 24 | 69 | 8 | 101 | 19 | 76 | 4 | 99 |
| ≥ 1 TEAE |
24
184.6%
|
69
328.6%
|
8
22.2%
|
101
325.8%
|
18
90%
|
75
576.9%
|
4
17.4%
|
97
225.6%
|
| ≥ 1 TEAE, Grade 3-4 |
20
153.8%
|
40
190.5%
|
5
13.9%
|
65
209.7%
|
10
50%
|
38
292.3%
|
4
17.4%
|
52
120.9%
|
| ≥ 1 TEAE, Grade 5 |
1
7.7%
|
13
61.9%
|
2
5.6%
|
16
51.6%
|
3
15%
|
8
61.5%
|
0
0%
|
11
25.6%
|
| ≥ 1 Serious TEAE |
16
123.1%
|
39
185.7%
|
5
13.9%
|
60
193.5%
|
10
50%
|
38
292.3%
|
3
13%
|
51
118.6%
|
| ≥ 1 Serious TEAE, Grade 3-4 |
16
123.1%
|
24
114.3%
|
3
8.3%
|
43
138.7%
|
6
30%
|
25
192.3%
|
3
13%
|
34
79.1%
|
| ≥ 1 Serious TEAE, Grade 5 |
0
0%
|
13
61.9%
|
2
5.6%
|
15
48.4%
|
3
15%
|
8
61.5%
|
0
0%
|
11
25.6%
|
| ≥ 1 Drug-Related (DR) Serious TEAE |
6
46.2%
|
20
95.2%
|
3
8.3%
|
29
93.5%
|
3
15%
|
14
107.7%
|
3
13%
|
20
46.5%
|
| ≥ 1 DR Serious TEAE, Grade 3-4 |
6
46.2%
|
15
71.4%
|
1
2.8%
|
22
71%
|
3
15%
|
8
61.5%
|
3
13%
|
14
32.6%
|
| ≥ 1 DR Serious TEAE, Grade 5 |
0
0%
|
2
9.5%
|
2
5.6%
|
4
12.9%
|
0
0%
|
2
15.4%
|
0
0%
|
2
4.7%
|
| ≥ 1 DR TEAE |
21
161.5%
|
64
304.8%
|
8
22.2%
|
93
300%
|
16
80%
|
68
523.1%
|
4
17.4%
|
88
204.7%
|
| ≥ 1 DR TEAE, Grade 3-4 |
14
107.7%
|
43
204.8%
|
3
8.3%
|
60
193.5%
|
6
30%
|
27
207.7%
|
4
17.4%
|
37
86%
|
| ≥ 1 DR TEAE, Grade 5 |
0
0%
|
2
9.5%
|
2
5.6%
|
4
12.9%
|
0
0%
|
2
15.4%
|
0
0%
|
2
4.7%
|
| ≥1 TEAE Leading to Study Drug Discontinuation (DC) |
4
30.8%
|
15
71.4%
|
5
13.9%
|
24
77.4%
|
5
25%
|
10
76.9%
|
2
8.7%
|
14
32.6%
|
| ≥ 1 TEAE Leading to Study Drug DC, Grade 3-4 |
2
15.4%
|
11
52.4%
|
2
5.6%
|
15
48.4%
|
4
20%
|
4
30.8%
|
2
8.7%
|
8
18.6%
|
| ≥1 TEAE Leading to Study Drug DC, Grade 5 |
0
0%
|
1
4.8%
|
2
5.6%
|
3
9.7%
|
1
5%
|
2
15.4%
|
0
0%
|
2
4.7%
|
| ≥ 1 DR TEAE Leading to Study Drug DC |
4
30.8%
|
10
47.6%
|
4
11.1%
|
18
58.1%
|
2
10%
|
10
76.9%
|
2
8.7%
|
14
32.6%
|
| ≥ 1 DR TEAE Leading to Study Drug DC, Grade 3-4 |
2
15.4%
|
7
33.3%
|
1
2.8%
|
10
32.3%
|
2
10%
|
4
30.8%
|
2
8.7%
|
8
18.6%
|
| ≥ 1 DR TEAE Leading to Study Drug DC, Grade 5 |
0
0%
|
1
4.8%
|
2
5.6%
|
3
9.7%
|
0
0%
|
2
15.4%
|
0
0%
|
2
4.7%
|
| ≥ 1 TEAE Leading to Dose Reduction |
0
0%
|
7
33.3%
|
2
5.6%
|
9
29%
|
0
0%
|
7
53.8%
|
0
0%
|
7
16.3%
|
| ≥ 1 TEAE Leading to Dose Reduction, Grade 3-4 |
0
0%
|
5
23.8%
|
1
2.8%
|
6
19.4%
|
0
0%
|
4
30.8%
|
0
0%
|
4
9.3%
|
| ≥ 1 TEAE Leading to Dose Reduction, Grade 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Objective Response Rate (ORR) |
|---|---|
| Description | ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Time Frame | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 13 | 21 | 36 | 31 | 20 | 13 | 23 | 43 |
| Number (95% Confidence Interval) [percentage of participants] |
7.7
59.2%
|
4.8
22.9%
|
13.9
38.6%
|
22.6
72.9%
|
10.0
50%
|
15.4
118.5%
|
4.3
18.7%
|
4.7
10.9%
|
| Title | Clinical Benefit Rate (CBR) |
|---|---|
| Description | CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol). |
| Time Frame | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 13 | 21 | 36 | 31 | 20 | 13 | 23 | 43 |
| Number (95% Confidence Interval) [percentage of participants] |
76.9
591.5%
|
76.2
362.9%
|
63.9
177.5%
|
61.3
197.7%
|
60.0
300%
|
76.9
591.5%
|
30.4
132.2%
|
46.5
108.1%
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates. |
| Time Frame | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: All enrolled participants who received any amount of study drug. Responders (CR or PR response). Presented by disease-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 2 | 4 | 9 | 8 | 3 | 2 | 1 | 3 |
| Median (95% Confidence Interval) [months] |
NA
|
3.0
|
2.6
|
6.7
|
NA
|
NA
|
4.6
|
3.9
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates. |
| Time Frame | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 13 | 21 | 36 | 31 | 20 | 13 | 23 | 43 |
| Median (95% Confidence Interval) [months] |
4.6
|
4.5
|
3.3
|
3.1
|
2.9
|
11.7
|
1.4
|
2.1
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates. |
| Time Frame | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: All enrolled participants who received any amount of study drug. Presented by disease-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | Large Cell Neuroendocrine Carcinoma | Neuroendocrine Prostate Cancer | Gastroenteropancreatic Neuroendocrine Carcinoma | Other Neuroendocrine Carcinoma | Malignant Melanoma | Medullary Thyroid Cancer | Glioblastoma | Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 13 | 21 | 36 | 31 | 20 | 13 | 23 | 43 |
| Median (95% Confidence Interval) [months] |
7.7
|
5.7
|
6.7
|
6.6
|
7.5
|
NA
|
6.6
|
5.5
|
| Title | Serum Concentrations of Rovalpituzumab Tesirine Over Time |
|---|---|
| Description | |
| Time Frame | Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least 1 dose of study drug and had an assessment at given time point. Presented by dose-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | 0.2 mg/kg | 0.3 mg/kg | 0.4 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 43 | 139 | 12 |
| Cycle 1: 0 hour |
0.057
(0.367)
|
0.044
(0.507)
|
0
(0)
|
| Cycle 1: 0.5 hour postdose |
4.799
(1.474)
|
7.351
(2.640)
|
10.785
(1.516)
|
| Cycle 1: 6 hours postdose |
4.377
(1.222)
|
6.710
(1.701)
|
9.355
(0.859)
|
| Cycle 1: 48 hours postdose |
2.760
(0.939)
|
4.483
(1.317)
|
6.049
(1.171)
|
| Cycle 1: 168 hours postdose |
1.494
(0.569)
|
2.392
(0.902)
|
3.250
(0.825)
|
| Cycle 1: 336 hours postdose |
0.963
(0.470)
|
1.633
(0.710)
|
2.302
(0.703)
|
| Cycle 1: 672 hours postdose |
0.515
(0.278)
|
0.976
(0.410)
|
1.272
(0.414)
|
| Title | Number of Participants With Anti-therapeutic Antibodies (ATA) |
|---|---|
| Description | Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study. |
| Time Frame | Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least 1 dose of study drug with available ATA data. Presented by dose-specific groups, inclusive of participants in parts A and B. |
| Arm/Group Title | 0.2 mg/kg | 0.3 mg/kg | 0.4 mg/kg |
|---|---|---|---|
| Arm/Group Description | Participants who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. |
| Measure Participants | 42 | 145 | 12 |
| Number [participants] |
5
38.5%
|
10
47.6%
|
1
2.8%
|
Adverse Events
| Time Frame | From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0). | |||||||||||||||||||||||||||||||||||||||||||
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| Adverse Event Reporting Description | No participants with malignant melanoma (MM) or medullary thyroid cancer (MTC) received the rovalpituzumab tesirine 0.4 mg/kg dose. | |||||||||||||||||||||||||||||||||||||||||||
| Arm/Group Title | 0.2_mg_kg_(LCNEC) | 0.2_mg_kg_(NEPC) | 0.2_mg_kg_(GEPNEC) | 0.2_mg_kg_(Other_NEC) | 0.2_mg_kg_(MM) | 0.2_mg_kg_(MTC) | 0.2_mg_kg_(GBM) | 0.2_mg_kg_(Other_Solid) | 0.3_mg_kg_(LCNEC) | 0.3_mg_kg_(NEPC) | 0.3_mg_kg_(GEPNEC) | 0.3_mg_kg_(Other_NEC) | 0.3_mg_kg_(MM) | 0.3_mg_kg_(MTC) | 0.3_mg_kg_(GBM) | 0.3_mg_kg_(Other_Solid) | 0.4_mg_kg_(GBM) | 0.4_mg_kg_(GEPNEC) | 0.4_mg_kg_(LCNEC) | 0.4_mg_kg_(NEPC) | 0.4_mg_kg_(Other_NEC) | 0.4_mg_kg_(Other_Solid) | ||||||||||||||||||||||
| Arm/Group Description | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.2 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with malignant melanoma (MM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with medullary thyroid cancer (MTC) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with glioblastoma (GBM) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with large cell neuroendocrine carcinoma (LCNEC) of any origin who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with neuroendocrine prostate cancer (NEPC) who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other neuroendocrine carcinoma (NEC), and high-grade neuroendocrine tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | Participants with other solid tumors who received rovalpituzumab tesirine 0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. | ||||||||||||||||||||||
All Cause Mortality |
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| 0.2_mg_kg_(LCNEC) | 0.2_mg_kg_(NEPC) | 0.2_mg_kg_(GEPNEC) | 0.2_mg_kg_(Other_NEC) | 0.2_mg_kg_(MM) | 0.2_mg_kg_(MTC) | 0.2_mg_kg_(GBM) | 0.2_mg_kg_(Other_Solid) | 0.3_mg_kg_(LCNEC) | 0.3_mg_kg_(NEPC) | 0.3_mg_kg_(GEPNEC) | 0.3_mg_kg_(Other_NEC) | 0.3_mg_kg_(MM) | 0.3_mg_kg_(MTC) | 0.3_mg_kg_(GBM) | 0.3_mg_kg_(Other_Solid) | 0.4_mg_kg_(GBM) | 0.4_mg_kg_(GEPNEC) | 0.4_mg_kg_(LCNEC) | 0.4_mg_kg_(NEPC) | 0.4_mg_kg_(Other_NEC) | 0.4_mg_kg_(Other_Solid) | |||||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 3/4 (75%) | 5/6 (83.3%) | 9/11 (81.8%) | 3/3 (100%) | 0/3 (0%) | 4/4 (100%) | 6/9 (66.7%) | 6/8 (75%) | 11/14 (78.6%) | 16/28 (57.1%) | 12/19 (63.2%) | 10/17 (58.8%) | 3/10 (30%) | 13/18 (72.2%) | 25/31 (80.6%) | 0/1 (0%) | 2/2 (100%) | 0/2 (0%) | 2/3 (66.7%) | 0/1 (0%) | 2/3 (66.7%) | ||||||||||||||||||||||
Serious Adverse Events |
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| 0.2_mg_kg_(LCNEC) | 0.2_mg_kg_(NEPC) | 0.2_mg_kg_(GEPNEC) | 0.2_mg_kg_(Other_NEC) | 0.2_mg_kg_(MM) | 0.2_mg_kg_(MTC) | 0.2_mg_kg_(GBM) | 0.2_mg_kg_(Other_Solid) | 0.3_mg_kg_(LCNEC) | 0.3_mg_kg_(NEPC) | 0.3_mg_kg_(GEPNEC) | 0.3_mg_kg_(Other_NEC) | 0.3_mg_kg_(MM) | 0.3_mg_kg_(MTC) | 0.3_mg_kg_(GBM) | 0.3_mg_kg_(Other_Solid) | 0.4_mg_kg_(GBM) | 0.4_mg_kg_(GEPNEC) | 0.4_mg_kg_(LCNEC) | 0.4_mg_kg_(NEPC) | 0.4_mg_kg_(Other_NEC) | 0.4_mg_kg_(Other_Solid) | |||||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | 3/4 (75%) | 2/6 (33.3%) | 9/11 (81.8%) | 2/3 (66.7%) | 1/3 (33.3%) | 2/4 (50%) | 5/9 (55.6%) | 6/8 (75%) | 8/14 (57.1%) | 15/28 (53.6%) | 10/19 (52.6%) | 8/17 (47.1%) | 3/10 (30%) | 8/18 (44.4%) | 19/31 (61.3%) | 0/1 (0%) | 2/2 (100%) | 1/2 (50%) | 2/3 (66.7%) | 0/1 (0%) | 3/3 (100%) | ||||||||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Anaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pancytopenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Thrombocytopenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cardiac disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Atrial fibrillation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Atrial flutter | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pericardial effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 1/10 (10%) | 1 | 1/18 (5.6%) | 1 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 2 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Supraventricular tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Abdominal distension | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 2 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ascites | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Constipation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Diarrhoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Duodenitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 1 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrointestinal haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Intestinal obstruction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pancreatitis acute | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Small intestinal obstruction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 1 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vomiting | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| General disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Fatigue | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gait disturbance | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Generalised oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Infusion site extravasation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Multiple organ dysfunction syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oedema peripheral | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pyrexia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 2 | 2/28 (7.1%) | 2 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Bile duct obstruction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cholangitis acute | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cholecystitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cholecystitis acute | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hepatic failure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hepatotoxicity | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperbilirubinaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Liver injury | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||||||||||||||||||||||||
| Abdominal abscess | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Bacteraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cellulitis | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Clostridial sepsis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Corona virus infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Device related infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 2 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Diverticulitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 2 | 1/18 (5.6%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Escherichia bacteraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumonia | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash pustular | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Sepsis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sepsis syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary tract infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urosepsis | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||||||||||||||
| Postoperative wound complication | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Subdural haematoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Investigations | ||||||||||||||||||||||||||||||||||||||||||||
| Blood bilirubin increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Liver function test increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Transaminases increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Troponin increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Dehydration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 4/31 (12.9%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Failure to thrive | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fluid overload | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 2 | 1/28 (3.6%) | 1 | 2/19 (10.5%) | 2 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercalcaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperglycaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypervolaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypokalaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyponatraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 2 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tumour lysis syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Arthralgia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Back pain | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 1/28 (3.6%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Bone pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Flank pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pain in extremity | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pathological fracture | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rhabdomyolysis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||||||||||||||
| Malignant neoplasm progression | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 2 | 2/14 (14.3%) | 2 | 7/28 (25%) | 7 | 1/19 (5.3%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 3/18 (16.7%) | 3 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Neoplasm malignant | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tumour haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 1 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tumour pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Brain oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cerebral haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cerebral infarction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hepatic encephalopathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Seizure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Toxic encephalopathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Confusional state | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 1 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Delirium | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Mental status changes | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acute kidney injury | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 2 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Hydronephrosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Renal impairment | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Renal injury | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acute respiratory failure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 2 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspnoea | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 0 | 3/31 (9.7%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Epistaxis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pleural effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 3 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 1/28 (3.6%) | 1 | 1/19 (5.3%) | 1 | 2/17 (11.8%) | 2 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Pleuritic pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumonia aspiration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumonitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 2 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pulmonary embolism | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 2 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pulmonary oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 1/31 (3.2%) | 1 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory failure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 2 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Rash maculo-papular | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Vascular disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Deep vein thrombosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Embolism | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypotension | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 1 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Jugular vein thrombosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 1 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Subclavian artery thrombosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||||||||||||||
| 0.2_mg_kg_(LCNEC) | 0.2_mg_kg_(NEPC) | 0.2_mg_kg_(GEPNEC) | 0.2_mg_kg_(Other_NEC) | 0.2_mg_kg_(MM) | 0.2_mg_kg_(MTC) | 0.2_mg_kg_(GBM) | 0.2_mg_kg_(Other_Solid) | 0.3_mg_kg_(LCNEC) | 0.3_mg_kg_(NEPC) | 0.3_mg_kg_(GEPNEC) | 0.3_mg_kg_(Other_NEC) | 0.3_mg_kg_(MM) | 0.3_mg_kg_(MTC) | 0.3_mg_kg_(GBM) | 0.3_mg_kg_(Other_Solid) | 0.4_mg_kg_(GBM) | 0.4_mg_kg_(GEPNEC) | 0.4_mg_kg_(LCNEC) | 0.4_mg_kg_(NEPC) | 0.4_mg_kg_(Other_NEC) | 0.4_mg_kg_(Other_Solid) | |||||||||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 4/4 (100%) | 6/6 (100%) | 11/11 (100%) | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 8/9 (88.9%) | 8/8 (100%) | 14/14 (100%) | 27/28 (96.4%) | 19/19 (100%) | 16/17 (94.1%) | 10/10 (100%) | 18/18 (100%) | 31/31 (100%) | 1/1 (100%) | 2/2 (100%) | 2/2 (100%) | 3/3 (100%) | 1/1 (100%) | 3/3 (100%) | ||||||||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Anaemia | 2/3 (66.7%) | 5 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 4/11 (36.4%) | 17 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 1 | 5/14 (35.7%) | 1 | 10/28 (35.7%) | 1 | 6/19 (31.6%) | 1 | 3/17 (17.6%) | 1 | 1/10 (10%) | 1 | 1/18 (5.6%) | 1 | 14/31 (45.2%) | 26 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 2/3 (66.7%) | 4 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Hypercoagulation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Leukocytosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Leukopenia | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 3/28 (10.7%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lymphadenopathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lymphopenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Neutropenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 2/19 (10.5%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Normocytic anaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Thrombocytopenia | 2/3 (66.7%) | 2 | 1/4 (25%) | 3 | 1/6 (16.7%) | 1 | 5/11 (45.5%) | 27 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 1/9 (11.1%) | 2 | 5/8 (62.5%) | 2 | 5/14 (35.7%) | 2 | 11/28 (39.3%) | 2 | 8/19 (42.1%) | 2 | 2/17 (11.8%) | 2 | 2/10 (20%) | 2 | 3/18 (16.7%) | 2 | 11/31 (35.5%) | 20 | 1/1 (100%) | 1 | 2/2 (100%) | 2 | 1/2 (50%) | 1 | 2/3 (66.7%) | 6 | 1/1 (100%) | 3 | 0/3 (0%) | 0 |
| Cardiac disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acute myocardial infarction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 2 | 0/8 (0%) | 2 | 0/14 (0%) | 2 | 0/28 (0%) | 2 | 0/19 (0%) | 2 | 0/17 (0%) | 2 | 0/10 (0%) | 2 | 0/18 (0%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Atrial fibrillation | 1/3 (33.3%) | 3 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Bradycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cardiac failure congestive | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Palpitations | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pericardial effusion | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 3 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 2/9 (22.2%) | 2 | 2/8 (25%) | 2 | 5/14 (35.7%) | 2 | 5/28 (17.9%) | 2 | 5/19 (26.3%) | 2 | 4/17 (23.5%) | 2 | 3/10 (30%) | 2 | 4/18 (22.2%) | 2 | 4/31 (12.9%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pericarditis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sinus tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 3/19 (15.8%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Ear congestion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vertigo | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Endocrine disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Adrenal insufficiency | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Conjunctival haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Diplopia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dry eye | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 1/19 (5.3%) | 1 | 1/17 (5.9%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye irritation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye pruritus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye swelling | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ocular discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Orbital oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Periorbital oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Photophobia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Uveitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vision blurred | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Visual impairment | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Abdominal discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/6 (33.3%) | 4 | 4/11 (36.4%) | 4 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 2/9 (22.2%) | 2 | 3/8 (37.5%) | 2 | 3/14 (21.4%) | 2 | 8/28 (28.6%) | 2 | 2/19 (10.5%) | 2 | 2/17 (11.8%) | 2 | 2/10 (20%) | 2 | 2/18 (11.1%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal pain lower | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/9 (22.2%) | 2 | 1/8 (12.5%) | 2 | 0/14 (0%) | 2 | 0/28 (0%) | 2 | 0/19 (0%) | 2 | 0/17 (0%) | 2 | 0/10 (0%) | 2 | 0/18 (0%) | 2 | 5/31 (16.1%) | 7 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal pain upper | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 2/9 (22.2%) | 2 | 1/8 (12.5%) | 2 | 3/14 (21.4%) | 2 | 0/28 (0%) | 2 | 1/19 (5.3%) | 2 | 3/17 (17.6%) | 2 | 0/10 (0%) | 2 | 0/18 (0%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal tenderness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ascites | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 3/14 (21.4%) | 0 | 6/28 (21.4%) | 0 | 2/19 (10.5%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 2/2 (100%) | 2 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Constipation | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 2/6 (33.3%) | 2 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 2/9 (22.2%) | 2 | 3/8 (37.5%) | 2 | 6/14 (42.9%) | 2 | 4/28 (14.3%) | 2 | 5/19 (26.3%) | 2 | 2/17 (11.8%) | 2 | 2/10 (20%) | 2 | 1/18 (5.6%) | 2 | 5/31 (16.1%) | 5 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 1/2 (50%) | 1 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Dental caries | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Diarrhoea | 2/3 (66.7%) | 2 | 1/4 (25%) | 1 | 2/6 (33.3%) | 3 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 1/4 (25%) | 2 | 0/9 (0%) | 0 | 3/8 (37.5%) | 0 | 5/14 (35.7%) | 0 | 4/28 (14.3%) | 0 | 1/19 (5.3%) | 0 | 3/17 (17.6%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 1/3 (33.3%) | 1 |
| Dry mouth | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 2/14 (14.3%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspepsia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 1/14 (7.1%) | 1 | 2/28 (7.1%) | 1 | 0/19 (0%) | 1 | 2/17 (11.8%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Dysphagia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Enteritis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Epigastric discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Eructation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Flatulence | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 2 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastritis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrointestinal inflammation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 2/10 (20%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Haematochezia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Haemorrhoidal haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Haemorrhoids | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lip dry | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Lip haemorrhage | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lip swelling | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Malabsorption | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nausea | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 2/6 (33.3%) | 4 | 5/11 (45.5%) | 6 | 1/3 (33.3%) | 2 | 3/3 (100%) | 3 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 4/8 (50%) | 1 | 6/14 (42.9%) | 1 | 9/28 (32.1%) | 1 | 9/19 (47.4%) | 1 | 5/17 (29.4%) | 1 | 3/10 (30%) | 1 | 4/18 (22.2%) | 1 | 10/31 (32.3%) | 10 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 2 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Oesophageal spasm | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oral pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pancreatic failure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pancreatitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Stomatitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Toothache | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Umbilical hernia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vomiting | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 3/6 (50%) | 3 | 4/11 (36.4%) | 4 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 3/9 (33.3%) | 3 | 3/8 (37.5%) | 3 | 4/14 (28.6%) | 3 | 3/28 (10.7%) | 3 | 4/19 (21.1%) | 3 | 3/17 (17.6%) | 3 | 1/10 (10%) | 3 | 6/18 (33.3%) | 3 | 6/31 (19.4%) | 7 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal distension | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 4/14 (28.6%) | 0 | 7/28 (25%) | 0 | 2/19 (10.5%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| General disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Asthenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 4/14 (28.6%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 5/31 (16.1%) | 8 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Catheter site pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Catheter site vesicles | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Chest discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Chest pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Chills | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Early satiety | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Face oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Facial pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fatigue | 1/3 (33.3%) | 2 | 1/4 (25%) | 1 | 3/6 (50%) | 6 | 5/11 (45.5%) | 7 | 3/3 (100%) | 3 | 1/3 (33.3%) | 3 | 3/4 (75%) | 9 | 5/9 (55.6%) | 5 | 7/8 (87.5%) | 5 | 8/14 (57.1%) | 5 | 0/28 (0%) | 5 | 10/19 (52.6%) | 5 | 9/17 (52.9%) | 5 | 4/10 (40%) | 5 | 10/18 (55.6%) | 5 | 13/31 (41.9%) | 18 | 1/1 (100%) | 1 | 1/2 (50%) | 2 | 2/2 (100%) | 3 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 1/3 (33.3%) | 1 |
| Feeling of body temperature change | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 14/28 (50%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gait disturbance | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/14 (14.3%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Generalised oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hernia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Influenza like illness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Infusion site erythema | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Injection site reaction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Localised oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Mass | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Non-cardiac chest pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oedema peripheral | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 3 | 6/11 (54.5%) | 13 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 2/9 (22.2%) | 2 | 5/8 (62.5%) | 2 | 7/14 (50%) | 2 | 7/28 (25%) | 2 | 3/19 (15.8%) | 2 | 5/17 (29.4%) | 2 | 3/10 (30%) | 2 | 3/18 (16.7%) | 2 | 9/31 (29%) | 13 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 1/3 (33.3%) | 1 |
| Pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 1/4 (25%) | 1 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Peripheral swelling | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 2/14 (14.3%) | 1 | 0/28 (0%) | 1 | 2/19 (10.5%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pyrexia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 3/14 (21.4%) | 0 | 4/28 (14.3%) | 0 | 3/19 (15.8%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 4/31 (12.9%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tenderness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Hyperbilirubinaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 3 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 9/28 (32.1%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 2/10 (20%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Jaundice | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ocular icterus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Portal fibrosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Immune system disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Immunodeficiency | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||||||||||||||||||||||||
| Abscess | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Bronchitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cellulitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Conjunctivitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cystitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Escherichia bacteraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fungal skin infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Klebsiella bacteraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nasopharyngitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oral candidiasis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Oral herpes | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Paronychia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Perineal cellulitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumonia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Purulent discharge | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rhinitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sinusitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Subcutaneous abscess | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tooth infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Upper respiratory tract infection | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary tract infection | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 4/19 (21.1%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 2/18 (11.1%) | 1 | 4/31 (12.9%) | 6 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Vulvovaginal mycotic infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||||||||||||||
| Arthropod bite | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Contusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 3 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Eye contusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fall | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/14 (14.3%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Infusion related reaction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Procedural pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sunburn | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tooth fracture | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Traumatic haematoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Investigations | ||||||||||||||||||||||||||||||||||||||||||||
| Alanine aminotransferase increased | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 4 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 3/8 (37.5%) | 1 | 2/14 (14.3%) | 1 | 10/28 (35.7%) | 1 | 2/19 (10.5%) | 1 | 0/17 (0%) | 1 | 3/10 (30%) | 1 | 3/18 (16.7%) | 1 | 3/31 (9.7%) | 5 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Amylase increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Aspartate aminotransferase increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 3 | 1/3 (33.3%) | 1 | 3/3 (100%) | 3 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 1 | 3/14 (21.4%) | 1 | 10/28 (35.7%) | 1 | 4/19 (21.1%) | 1 | 0/17 (0%) | 1 | 2/10 (20%) | 1 | 3/18 (16.7%) | 1 | 5/31 (16.1%) | 11 | 0/1 (0%) | 0 | 1/2 (50%) | 3 | 1/2 (50%) | 1 | 3/3 (100%) | 7 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Bilirubin conjugated increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Blood alkaline phosphatase increased | 0/3 (0%) | 0 | 1/4 (25%) | 4 | 1/6 (16.7%) | 1 | 4/11 (36.4%) | 5 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 1 | 2/14 (14.3%) | 1 | 8/28 (28.6%) | 1 | 2/19 (10.5%) | 1 | 2/17 (11.8%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 3/31 (9.7%) | 6 | 0/1 (0%) | 0 | 2/2 (100%) | 4 | 0/2 (0%) | 0 | 2/3 (66.7%) | 2 | 1/1 (100%) | 5 | 0/3 (0%) | 0 |
| Blood bilirubin increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 5 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Blood creatinine increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Blood lactate dehydrogenase increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Blood lactic acid increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Electrocardiogram QT prolonged | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Gamma-glutamyltransferase increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Glomerular filtration rate decreased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Heart rate increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| International normalised ratio increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Prothrombin time prolonged | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Troponin I increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Weight decreased | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Weight increased | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/14 (14.3%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acidosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cachexia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Decreased appetite | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 2/6 (33.3%) | 4 | 4/11 (36.4%) | 6 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 1/4 (25%) | 1 | 2/9 (22.2%) | 2 | 3/8 (37.5%) | 2 | 10/14 (71.4%) | 2 | 5/28 (17.9%) | 2 | 4/19 (21.1%) | 2 | 6/17 (35.3%) | 2 | 0/10 (0%) | 2 | 3/18 (16.7%) | 2 | 11/31 (35.5%) | 11 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 2/2 (100%) | 2 | 1/3 (33.3%) | 1 | 1/1 (100%) | 2 | 1/3 (33.3%) | 1 |
| Dehydration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/14 (21.4%) | 0 | 3/28 (10.7%) | 0 | 2/19 (10.5%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Diabetes mellitus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fluid intake reduced | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Fluid overload | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperammonaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperamylasaemia | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercalcaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercholesterolaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperglycaemia | 1/3 (33.3%) | 3 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 2/8 (25%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 2/17 (11.8%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 5 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperkalaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperlipasaemia | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 2 | 0/3 (0%) | 0 |
| Hyperlipidaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypermagnesaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypernatraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoalbuminaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 4/11 (36.4%) | 6 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 3/8 (37.5%) | 1 | 0/14 (0%) | 1 | 6/28 (21.4%) | 1 | 2/19 (10.5%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 5/31 (16.1%) | 7 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 2 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Hypocalcaemia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 4 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoglycaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 5 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypokalaemia | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 5/11 (45.5%) | 9 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/9 (0%) | 0 | 4/8 (50%) | 0 | 3/14 (21.4%) | 0 | 3/28 (10.7%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 6/31 (19.4%) | 11 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypomagnesaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyponatraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/4 (50%) | 4 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 1/14 (7.1%) | 0 | 3/28 (10.7%) | 0 | 2/19 (10.5%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 2/18 (11.1%) | 0 | 3/31 (9.7%) | 14 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypophosphataemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 5 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 1/14 (7.1%) | 1 | 2/28 (7.1%) | 1 | 2/19 (10.5%) | 1 | 0/17 (0%) | 1 | 1/10 (10%) | 1 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vitamin B6 deficiency | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Arthralgia | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 0/6 (0%) | 0 | 3/11 (27.3%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 5/28 (17.9%) | 0 | 2/19 (10.5%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 5/31 (16.1%) | 7 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 3 | 0/3 (0%) | 0 |
| Back pain | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 2/14 (14.3%) | 1 | 3/28 (10.7%) | 1 | 2/19 (10.5%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 6/31 (19.4%) | 6 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Flank pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Groin pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Haemarthrosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercreatinaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Joint effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Joint range of motion decreased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Joint swelling | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Limb discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Muscle spasms | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Muscular weakness | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal chest pain | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 1/19 (5.3%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal stiffness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Myalgia | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 3/28 (10.7%) | 0 | 1/19 (5.3%) | 0 | 3/17 (17.6%) | 0 | 2/10 (20%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 1/2 (50%) | 2 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Neck pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 2 | 0/8 (0%) | 2 | 0/14 (0%) | 2 | 0/28 (0%) | 2 | 0/19 (0%) | 2 | 0/17 (0%) | 2 | 0/10 (0%) | 2 | 0/18 (0%) | 2 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Osteoarthritis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pain in extremity | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 3/14 (21.4%) | 1 | 2/28 (7.1%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Pain in jaw | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Plantar fasciitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Spinal column stenosis | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tendonitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||||||||||||||
| Basal cell carcinoma | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cancer pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Malignant neoplasm progression | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tumour pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Aphasia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Asterixis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Ataxia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Brain oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cerebral haematoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Disturbance in attention | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dizziness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 5/14 (35.7%) | 1 | 4/28 (14.3%) | 1 | 2/19 (10.5%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dizziness postural | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dysaesthesia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dysgeusia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 3/8 (37.5%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 2/17 (11.8%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Encephalopathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Head discomfort | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Headache | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 3/11 (27.3%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 3/19 (15.8%) | 1 | 2/17 (11.8%) | 1 | 2/10 (20%) | 1 | 2/18 (11.1%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hemiparesis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hydrocephalus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypersomnia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoaesthesia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lethargy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Mental impairment | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolic encephalopathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Migraine | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Neuropathy peripheral | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Paraesthesia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Peripheral sensory neuropathy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Somnolence | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 3/10 (30%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Spinal cord compression | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Syncope | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tremor | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Product Issues | ||||||||||||||||||||||||||||||||||||||||||||
| Device occlusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Agitation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Anxiety | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Compulsions | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Confusional state | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Delusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Depressed mood | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Depression | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hallucination | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Insomnia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/4 (0%) | 0 | 2/9 (22.2%) | 2 | 1/8 (12.5%) | 2 | 3/14 (21.4%) | 2 | 2/28 (7.1%) | 2 | 3/19 (15.8%) | 2 | 2/17 (11.8%) | 2 | 1/10 (10%) | 2 | 1/18 (5.6%) | 2 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 2/3 (66.7%) | 2 |
| Irritability | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Major depression | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sleep disorder | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acute kidney injury | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Bladder spasm | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Chronic kidney disease | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dysuria | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Glycosuria | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Haematuria | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Micturition urgency | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nephrolithiasis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nocturia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pollakiuria | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Polyuria | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Renal vein thrombosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary incontinence | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary retention | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Urine flow decreased | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Proteinuria | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Female genital tract fistula | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Menorrhagia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pelvic pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Penile pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Perineal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Scrotal erythema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Scrotal oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Scrotal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Sexual dysfunction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vaginal haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspnoea | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/9 (11.1%) | 3 | 5/8 (62.5%) | 3 | 5/14 (35.7%) | 3 | 5/28 (17.9%) | 3 | 6/19 (31.6%) | 3 | 4/17 (23.5%) | 3 | 4/10 (40%) | 3 | 3/18 (16.7%) | 3 | 3/31 (9.7%) | 4 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Hiccups | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 1/18 (5.6%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Acquired diaphragmatic eventration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Asthma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Atelectasis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Cough | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 3/8 (37.5%) | 0 | 5/14 (35.7%) | 0 | 5/28 (17.9%) | 0 | 1/19 (5.3%) | 0 | 3/17 (17.6%) | 0 | 2/10 (20%) | 0 | 2/18 (11.1%) | 0 | 4/31 (12.9%) | 4 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Dry throat | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dysphonia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspnoea exertional | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 5 | 1/1 (100%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspnoea paroxysmal nocturnal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Epistaxis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 1/14 (7.1%) | 1 | 2/28 (7.1%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoxia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Increased bronchial secretion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Lung infiltration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nasal congestion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Oropharyngeal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 2/28 (7.1%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pleural effusion | 2/3 (66.7%) | 2 | 1/4 (25%) | 1 | 2/6 (33.3%) | 3 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 6/8 (75%) | 1 | 4/14 (28.6%) | 1 | 8/28 (28.6%) | 1 | 6/19 (31.6%) | 1 | 4/17 (23.5%) | 1 | 3/10 (30%) | 1 | 5/18 (27.8%) | 1 | 5/31 (16.1%) | 8 | 0/1 (0%) | 0 | 2/2 (100%) | 2 | 2/2 (100%) | 4 | 1/3 (33.3%) | 1 | 1/1 (100%) | 2 | 0/3 (0%) | 0 |
| Pneumonia aspiration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumonitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pneumothorax | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Productive cough | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pulmonary embolism | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pulmonary oedema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rhinorrhoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Tachypnoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Upper respiratory tract congestion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Upper-airway cough syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 |
| Wheezing | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Alopecia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Blister | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dermatitis acneiform | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Dry skin | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 2/19 (10.5%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 3 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Ecchymosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Erythema | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/11 (9.1%) | 3 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 3/31 (9.7%) | 5 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 2 | 0/3 (0%) | 0 |
| Erythema multiforme | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Exfoliative rash | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 4 | 0/8 (0%) | 4 | 0/14 (0%) | 4 | 0/28 (0%) | 4 | 0/19 (0%) | 4 | 0/17 (0%) | 4 | 0/10 (0%) | 4 | 0/18 (0%) | 4 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperhidrosis | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nail bed disorder | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Nail discolouration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 0/17 (0%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pain of skin | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Palmar erythema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 2 | 1/3 (33.3%) | 1 |
| Petechiae | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Photosensitivity reaction | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 1/6 (16.7%) | 2 | 3/11 (27.3%) | 4 | 0/3 (0%) | 0 | 3/3 (100%) | 5 | 0/4 (0%) | 0 | 2/9 (22.2%) | 3 | 2/8 (25%) | 3 | 2/14 (14.3%) | 3 | 10/28 (35.7%) | 3 | 2/19 (10.5%) | 3 | 5/17 (29.4%) | 3 | 5/10 (50%) | 3 | 5/18 (27.8%) | 3 | 6/31 (19.4%) | 7 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 1/2 (50%) | 2 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pigmentation disorder | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pruritus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/11 (18.2%) | 2 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 2/28 (7.1%) | 0 | 2/19 (10.5%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Pruritus generalised | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/11 (27.3%) | 4 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 2/17 (11.8%) | 1 | 2/10 (20%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash erythematous | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 0/17 (0%) | 0 | 1/10 (10%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash macular | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 3/19 (15.8%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash maculo-papular | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 2/11 (18.2%) | 2 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 2/8 (25%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 1/10 (10%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 2 |
| Rash papular | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 2/17 (11.8%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash pruritic | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Rash vesicular | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 2/14 (14.3%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Skin exfoliation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 0/14 (0%) | 1 | 0/28 (0%) | 1 | 0/19 (0%) | 1 | 1/17 (5.9%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Skin hyperpigmentation | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 1/19 (5.3%) | 1 | 1/17 (5.9%) | 1 | 1/10 (10%) | 1 | 0/18 (0%) | 1 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Swelling face | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 2 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 1 | 1/14 (7.1%) | 1 | 0/28 (0%) | 1 | 1/19 (5.3%) | 1 | 0/17 (0%) | 1 | 0/10 (0%) | 1 | 0/18 (0%) | 1 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Toxic erythema of chemotherapy | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||||||||||||||||||||||||||
| Capillary leak syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 0/18 (0%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Deep vein thrombosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Flushing | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/14 (7.1%) | 0 | 2/28 (7.1%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hot flush | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypertension | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/11 (9.1%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 1/8 (12.5%) | 0 | 0/14 (0%) | 0 | 3/28 (10.7%) | 0 | 1/19 (5.3%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 2/18 (11.1%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
| Hypotension | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 3/8 (37.5%) | 0 | 3/14 (21.4%) | 0 | 0/28 (0%) | 0 | 3/19 (15.8%) | 0 | 1/17 (5.9%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 2/31 (6.5%) | 2 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Thrombophlebitis superficial | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/11 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/14 (0%) | 0 | 0/28 (0%) | 0 | 0/19 (0%) | 0 | 0/17 (0%) | 0 | 0/10 (0%) | 0 | 1/18 (5.6%) | 0 | 0/31 (0%) | 0 | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT02709889
Other Study ID Numbers:
- SCRX001-006
First Posted:
Mar 16, 2016
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020