Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Sponsor
Tracon Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03780010
Collaborator
University of Alabama at Birmingham (Other)
15
1
45
Study Details
Study Description
Brief Summary
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC) patients when given with carboplatin and paclitaxel. TRC105 is an antibody to endoglin, an essential angiogenic target expressed on proliferating endothelial cells that is distinct from the VEGFR and overexpressed in response to VEGF inhibition. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of antibodies and small molecules that target the VEGFR. In a phase 1b study, the combination of TRC105 and bevacizumab produced radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well tolerated. TRC105 was also well tolerated with chemotherapy in a trial with capecitabine in breast cancer patients. The use of TRC105 with bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin alone.
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Dose-escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer
Actual Study Start Date
:
Sep 1, 2015
Actual Primary Completion Date
:
Jun 1, 2019
Actual Study Completion Date
:
Jun 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TRC105 + B + P + C TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC. |
Drug: TRC105
Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment-Emergent Adverse Events [from screening until completion of follow-up, on average 6 months]
Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
Secondary Outcome Measures
- Overall RECIST 1.1 Response Rate [6 months]
Response rate determined according to RECIST 1.1 criteria
- Percent of Patients With Progression-free Survival (PFS) at 6 Months [6 months]
Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
- Median Progression Free Survival [months]
Median duration of progression free survival according to RECIST 1.1 criteria
- Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin [3 months]
Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
- Number of Patients Who Have TRC105 Positive Anti-Product Antibodies [6 months]
Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
-
ECOG performance status ≤ 1
-
Measurable disease by RECIST
Key Exclusion Criteria:
-
Non-small cell lung cancer of squamous histology
-
Current treatment on another therapeutic clinical trial
-
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
-
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tracon Pharmaceuticals Inc.
- University of Alabama at Birmingham
Investigators
- Study Director: Charles Theuer, MD, TRACON Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03780010
Other Study ID Numbers:
- 105LC101
First Posted:
Dec 19, 2018
Last Update Posted:
Oct 28, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | medical clinic |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose Level 1: 8 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC | Dose Level 2: 10 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC |
| Period Title: Overall Study | ||
| STARTED | 3 | 12 |
| COMPLETED | 3 | 12 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Total |
|---|---|---|---|
| Arm/Group Description | Dose Level 1: 8 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC. | Dose Level 2: 10 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC. | Total of all reporting groups |
| Overall Participants | 3 | 12 | 15 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
69
|
70
|
69
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
66.7%
|
6
50%
|
8
53.3%
|
| Male |
1
33.3%
|
6
50%
|
7
46.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
3
100%
|
12
100%
|
15
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
8.3%
|
1
6.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
16.7%
|
2
13.3%
|
| White |
3
100%
|
9
75%
|
12
80%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
3
100%
|
12
100%
|
15
100%
|
| Number of prior regimens (number of prior regimens) [Median (Full Range) ] | |||
| Median (Full Range) [number of prior regimens] |
0
|
0
|
0
|
Outcome Measures
| Title | Treatment-Emergent Adverse Events |
|---|---|
| Description | Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03 |
| Time Frame | from screening until completion of follow-up, on average 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin) |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 12 |
| Participants who experienced an AE |
3
100%
|
12
100%
|
| Participants who experienced a TRC105 related AE |
3
100%
|
11
91.7%
|
| Participants who experienced a Bev related AE |
3
100%
|
10
83.3%
|
| Participants who experienced a Carbo related AE |
3
100%
|
12
100%
|
| Participants who experienced a Pac related AE |
3
100%
|
12
100%
|
| Title | Overall RECIST 1.1 Response Rate |
|---|---|
| Description | Response rate determined according to RECIST 1.1 criteria |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 1: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 12 |
| Stable Disease Best Response |
2
66.7%
|
9
75%
|
| Partial Response Best Response |
1
33.3%
|
3
25%
|
| Progressive Disease Best Response |
0
0%
|
0
0%
|
| Complete Response Best Response |
0
0%
|
0
0%
|
| Title | Percent of Patients With Progression-free Survival (PFS) at 6 Months |
|---|---|
| Description | Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients progression free according to RECIST 1.1 after 6 months of treatment |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 10 |
| Count of Participants [Participants] |
1
33.3%
|
7
58.3%
|
| Title | Median Progression Free Survival |
|---|---|
| Description | Median duration of progression free survival according to RECIST 1.1 criteria |
| Time Frame | months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients progression free according to RECIST 1.1 after 6 months of treatment |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 110 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 10 |
| Median (Standard Deviation) [Months] |
3
(1.73)
|
6.5
(3.35)
|
| Title | Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin |
|---|---|
| Description | Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 12 |
| Mean (Full Range) [ng/mL] |
56600
|
103228
|
| Title | Number of Patients Who Have TRC105 Positive Anti-Product Antibodies |
|---|---|
| Description | Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study |
| Arm/Group Title | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
|---|---|---|
| Arm/Group Description | Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin |
| Measure Participants | 3 | 11 |
| Ptn with low titer treatment emergent ADA |
0
0%
|
1
8.3%
|
| Ptn without treatment emergent ADA |
3
100%
|
10
83.3%
|
Adverse Events
| Time Frame | From screening until completion of follow-up, on average 6 months | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||
| Arm/Group Title | TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | |||||||||||
| Arm/Group Description | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin. | |||||||||||
All Cause Mortality |
||||||||||||||||||||||
| TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | ||||||||||||
| 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 | 1/15 (6.7%) | 0/1 (0%) | 0/12 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/2 (0%) | 0/1 (0%) | |||||||||||
Serious Adverse Events |
||||||||||||||||||||||
| TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | ||||||||||||
| 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 | 3/15 (20%) | 0/1 (0%) | 1/12 (8.3%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/5 (20%) | 1/5 (20%) | 2/5 (40%) | 2/2 (100%) | 0/1 (0%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Hematemesis | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||||||||||||
| Non Cardiac Chest Pain | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Weakness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||
| Appendicitis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sepsis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Pneumonia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Left arm wound infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Febrile Neutropenic Sepsis | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Left forearm wound/degloving injury | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||
| Hypertensive Encephalopathy | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||
| Altered Mental Status | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Hypoxemia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypoxia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||
| TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | ||||||||||||
| 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 | 15/15 (100%) | 1/1 (100%) | 12/12 (100%) | 5/5 (100%) | 6/6 (100%) | 7/9 (77.8%) | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) | 2/2 (100%) | 1/1 (100%) | |||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||
| Anemia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 2/5 (40%) | 5 | 0/6 (0%) | 0 | 2/9 (22.2%) | 13 | 2/5 (40%) | 5 | 1/5 (20%) | 2 | 3/5 (60%) | 4 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Leukocytosis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Leukopenia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Neutropenia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 2 | 0/1 (0%) | 0 |
| Thrombocytopenia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 2/9 (22.2%) | 3 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/2 (50%) | 3 | 1/1 (100%) | 1 |
| Cardiac disorders | ||||||||||||||||||||||
| Atrial Fibrillation | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent atrial fibrillation | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Intermittent tachycardia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Left Ventricular Dysfunction | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Occasional Palpitations | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Tachycardia | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||||||||||||
| Earache | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Endocrine disorders | ||||||||||||||||||||||
| Hypothyroidism | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Eye disorders | ||||||||||||||||||||||
| Dry Eyes | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Eye floaters | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Visual Disturbance | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||
| Abdominal Cramps | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal Discomfort | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Anal hemorrhage | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Belching | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Bleeding gums | 0/15 (0%) | 0 | 1/1 (100%) | 1 | 0/12 (0%) | 0 | 2/5 (40%) | 2 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Bleeding hemorrhoids | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Constipation | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 3 | 2/2 (100%) | 2 | 0/1 (0%) | 0 |
| Constipation intermittent | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Diarrhea | 2/15 (13.3%) | 4 | 0/1 (0%) | 0 | 5/12 (41.7%) | 6 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 3/9 (33.3%) | 9 | 1/5 (20%) | 3 | 0/5 (0%) | 0 | 3/5 (60%) | 10 | 1/2 (50%) | 2 | 0/1 (0%) | 0 |
| Diarrhea, Intermittent | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dry Mouth | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Emesis | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Flatulence | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Gingival Bleeding | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Gingival Ulcer | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Gingivitis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Gum Bleeding | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Heartburn | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hematemesis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hemorrhoids | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent Constipation | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent left lower quadrant abdominal pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent Diarrhea | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent Constipation | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Loose bowel movement | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Mouth pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Mouth Soreness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Nausea | 9/15 (60%) | 10 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 3/5 (60%) | 4 | 1/6 (16.7%) | 1 | 2/9 (22.2%) | 7 | 2/5 (40%) | 3 | 1/5 (20%) | 2 | 3/5 (60%) | 4 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Oral Pain | 1/15 (6.7%) | 1 | 1/1 (100%) | 2 | 1/12 (8.3%) | 1 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 1/9 (11.1%) | 2 | 2/5 (40%) | 3 | 2/5 (40%) | 4 | 1/5 (20%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Periodontal Disease | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Rectal Bleeding | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| RUQ Tenderness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sore mouth | 3/15 (20%) | 3 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 4 | 1/2 (50%) | 2 | 0/1 (0%) | 0 |
| Tooth loss | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Tooth pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Ulceration, right corner of mouth | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Vomiting | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Worsening GERD | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||||||||||||
| Ankle edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Bilateral Ankle edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Central chest pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Chest Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Chest Pain non cardiac | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Chills | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Cold intolerance | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Fatigue | 5/15 (33.3%) | 6 | 1/1 (100%) | 1 | 3/12 (25%) | 3 | 2/5 (40%) | 3 | 3/6 (50%) | 6 | 3/9 (33.3%) | 15 | 3/5 (60%) | 8 | 3/5 (60%) | 13 | 5/5 (100%) | 31 | 2/2 (100%) | 11 | 1/1 (100%) | 1 |
| Fever | 1/15 (6.7%) | 2 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Flu like symptoms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Generalized weakness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| IV infiltration during pre-med Emend administration | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Left hand edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Lower Extremity Edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Musositis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 5 | 0/5 (0%) | 0 | 1/5 (20%) | 3 | 2/2 (100%) | 5 | 0/1 (0%) | 0 |
| Non cardiac chest pain | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, right posterior chest | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pedal Edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Perineal cyst rupture | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pleurex catheter site irritation | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right ankle edema | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right chest discomfort | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Swelling/fullness to left supraclavicular area | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Weakness | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Wound dehiscence port area | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Immune system disorders | ||||||||||||||||||||||
| Allergy symptoms, sneezing | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||
| Bladder infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Bronchitis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Clostridium Difficile Infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Cold Sores | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Cold Symptoms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Facial Cellulitis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Gingival abscess | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Mucosal infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pneumonia | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory cold symptoms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sepsis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Skin infection from perianal cyst | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Skin infection left lower leg | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Tooth infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Upper respiratory infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Urinary tract infection | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Wound infection port area | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Abrasions arms and face | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Fall | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Infusion Reaction | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Left forearm wound | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pathological pelvic fracture | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Upper arm lacerations | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||||||||||||||||||
| Decreased Platelet Count | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Elevated TSH | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Weight loss | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 3 | 2/5 (40%) | 2 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||
| Anorexia | 3/15 (20%) | 3 | 0/1 (0%) | 0 | 2/12 (16.7%) | 2 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 2/9 (22.2%) | 3 | 2/5 (40%) | 3 | 2/5 (40%) | 4 | 3/5 (60%) | 6 | 1/2 (50%) | 1 | 1/1 (100%) | 2 |
| Dehydration | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypernatremia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypokalemia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypomagnesemia | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Hyponatremia | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Loss of appetite | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Arthralgia | 4/15 (26.7%) | 8 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 2/6 (33.3%) | 4 | 2/9 (22.2%) | 12 | 1/5 (20%) | 1 | 2/5 (40%) | 5 | 2/5 (40%) | 7 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
| Arthralgia Knees | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Arthralgias | 4/15 (26.7%) | 7 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 12 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
| Back Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Cramps Extremities | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hip pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Jaw Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Left Ankle Swelling | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Left arm pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Left lower leg pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Left shoulder pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Leg Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 2/5 (40%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Leg weakness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Myalgia | 8/15 (53.3%) | 10 | 0/1 (0%) | 0 | 2/12 (16.7%) | 2 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 2/5 (40%) | 5 | 1/5 (20%) | 6 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Neck Spasms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Pain arm, leg, back | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, back | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain beneath right shoulder blade | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, bilateral legs | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, L hip | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, right hand | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pain, neck | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right flank pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right knee pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right shoulder pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Swelling, ankles | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||
| Dizziness | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Dizziness upon rising | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dysgeusia | 5/15 (33.3%) | 5 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 3/5 (60%) | 3 | 2/5 (40%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Encephalopathy | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 7 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Facial Numbness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hand tremors | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Headache | 3/15 (20%) | 3 | 1/1 (100%) | 1 | 6/12 (50%) | 7 | 1/5 (20%) | 1 | 2/6 (33.3%) | 4 | 2/9 (22.2%) | 5 | 2/5 (40%) | 3 | 1/5 (20%) | 22 | 2/5 (40%) | 14 | 2/2 (100%) | 3 | 1/1 (100%) | 2 |
| Intermittent headaches | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Memory impairment | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Migraine | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Neuropathy | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 3/6 (50%) | 4 | 2/9 (22.2%) | 6 | 1/5 (20%) | 2 | 2/5 (40%) | 8 | 3/5 (60%) | 5 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Neuropathy, fingers | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 2 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Neuropathy, feet | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 5 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Paresthesia | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 3 | 1/5 (20%) | 3 | 1/5 (20%) | 2 | 1/2 (50%) | 2 | 0/1 (0%) | 0 |
| Presyncope | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Restless leg | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Right hand tremors | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Short term memory loss | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Sleepiness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Syncope | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Taste disturbances | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Temporal headache | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||
| Anxiety | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Auditory Hallucinations | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Confusion | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Depression | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Insomnia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Restlessness | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||
| Acute kidney injury | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dysuria | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hematuria | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Leukocyturia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Patchy perfusion of the kidneys | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Proteinuria | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Urinary retention | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||||
| Right pelvic pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 3 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Vaginal Bleeding | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Vaginal Tenderness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Allergic Rhinitis | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Blood in sputum | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Blood with sinus drainage | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Chest Congestion | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| COPD Exacerbation | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Cough | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 5 | 0/5 (0%) | 0 | 2/5 (40%) | 4 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Dyspnea | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Epistaxis | 1/15 (6.7%) | 1 | 1/1 (100%) | 1 | 2/12 (16.7%) | 5 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 4/9 (44.4%) | 9 | 3/5 (60%) | 5 | 2/5 (40%) | 3 | 2/5 (40%) | 8 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
| Erythematous Rash, both hands | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hemoptysis | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hiccups | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hoarseness | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypoxemia | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypoxemic Respiratory Failure | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypoxia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Increased Phlegm | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent Cough | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent shortness of breath | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Nasal Congestion | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Nose bleed | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
| Nose pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pleural Effusion | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pneumothorax | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Productive cough | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 3 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Pulmonary Embolism | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Shortness of breath | 1/15 (6.7%) | 1 | 1/1 (100%) | 1 | 1/12 (8.3%) | 2 | 2/5 (40%) | 2 | 0/6 (0%) | 0 | 2/9 (22.2%) | 3 | 2/5 (40%) | 3 | 2/5 (40%) | 5 | 4/5 (80%) | 8 | 2/2 (100%) | 5 | 1/1 (100%) | 2 |
| Sinus Congestion | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sinus Drainage | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sinus Pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 2 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Sore throat | 5/15 (33.3%) | 7 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 3/5 (60%) | 7 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Throat pain | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Acneform rash, scalp | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Acneiform rash, face | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Alopecia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 1/5 (20%) | 1 | 3/6 (50%) | 3 | 3/9 (33.3%) | 3 | 2/5 (40%) | 2 | 2/5 (40%) | 2 | 2/5 (40%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dry Skin | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dry Skin, Face | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Dry, hyperpigmented skin - posterior neck | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Erythema, palms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 2 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hair Loss | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Macropopular rash, bilateral arms | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Rash | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 2/5 (40%) | 3 | 2/5 (40%) | 5 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
| Redness, right hand | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Redness, groin | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Skin Ulceration | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Swelling right eyebrow area | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Telangiectasia | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/9 (11.1%) | 1 | 3/5 (60%) | 3 | 2/5 (40%) | 5 | 4/5 (80%) | 8 | 2/2 (100%) | 2 | 0/1 (0%) | 0 |
| Warty scalp lesion | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||||
| Flushing | 2/15 (13.3%) | 2 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Hypertension | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
| Hypotension | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Intermittent Hypotension | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Phlebitis, left arm | 1/15 (6.7%) | 1 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Phlebitis, right arm | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 1/12 (8.3%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
| Thromboembolic event (DVT) | 0/15 (0%) | 0 | 0/1 (0%) | 0 | 0/12 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/2 (0%) | 0 | 1/1 (100%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Medical Monitor |
|---|---|
| Organization | TRACON Pharmaceuticals Inc |
| Phone | 8585500780 |
| clinicaltrials@traconpharma.com |
Responsible Party:
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03780010
Other Study ID Numbers:
- 105LC101
First Posted:
Dec 19, 2018
Last Update Posted:
Oct 28, 2019
Last Verified:
Oct 1, 2019