A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Study Details
Study Description
Brief Summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1, Group X
|
Drug: LBH589
|
Experimental: Arm 1, Group Y
|
Drug: LBH589
|
Experimental: Arm 2, Group X
|
Drug: LBH589
|
Experimental: Arm 2, Group Y Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
Drug: LBH589
|
Outcome Measures
Primary Outcome Measures
- Number of Participants DLT in Arm 1 in Dose Escalation Phase [Cycle 1 (28-day treatment cycle)]
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
- Number of Participants DLT in Arm 2 in Dose Escalation Phase [Cycle 1 (28-day treamtent cycle)]
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Secondary Outcome Measures
- Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) [3.5 years]
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
- Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase [1.2 years]
Stage 2 did not open for enrollment.
- Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) [3.5 years]
Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
- Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) [3.5 years]
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
- Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 [Day 1]
- Half Life of Panobinostat After the First Dose in Arms 1 and 2 [Day 1]
- Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 [Day 15]
From day 15 by dose with schedule: MWF every week
- Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 [Day 15]
- Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 [Day 15/day 1]
MWF Every week schedule n = number of subjects with non-missing values.
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X [Days 1, 5, 8, 10, 15]
Reporting the number of patients with a reading at the timepoint in the dose group.
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y [Days 5, 8, end of study (up to 3.5 years)]
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X [Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)]
- Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y [Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)]
- Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) [Post dose to pre-dose (up to 3.5 years)]
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
- Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) [Post dose to pre-dose (up to 3.5 years)]
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Eligibility Criteria
Criteria
Inclusion criteria:
-
Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
-
World Health Organization (WHO) performance status ≤ 2
-
Patients who met protocol-specified hematologic and non-hematologic laboratory values
-
Patients with adequate liver and renal function
Exclusion criteria:
-
Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
-
Peripheral neuropathy ≥ CTCAE grade 2
-
Unresolved diarrhea ≥ CTCAE grade 2
-
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
-
Female patients who were pregnant or breast feeding
-
Patients who were unwilling to use an effective method of birth control
-
Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
-
Patients with another primary malignancy that required active intervention or were clinically significant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia | Augusta | Georgia | United States | 30912 |
2 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
3 | MD Anderson Cancer Center/University of Texas | Houston | Texas | United States | 77030 |
4 | Novartis Investigative Site | Parkville | Victoria | Australia | 3002 |
5 | Novartis Investigative Site | Prahran | Victoria | Australia | 3181 |
6 | Novartis Investigative Site | Frankfurt/M | Germany | 60590 | |
7 | Novartis Investigative Site | Mainz | Germany | 55131 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CLBH589B2102
- 2005-003670-26
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm 1, Group X | Arm 1, Group Y | Arm 2, Group X | Arm 2, Group Y |
---|---|---|---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
Period Title: Overall Study | ||||
STARTED | 86 | 34 | 33 | 23 |
COMPLETED | 0 | 0 | 0 | 0 |
NOT COMPLETED | 86 | 34 | 33 | 23 |
Baseline Characteristics
Arm/Group Title | Arm 1, Group X | Arm 1, Group Y | Arm 2, Group X | Arm 2, Group Y | Total |
---|---|---|---|---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | Total of all reporting groups |
Overall Participants | 86 | 34 | 33 | 23 | 176 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
64.2
(12.11)
|
41.1
(17.27)
|
68.7
(8.75)
|
48.3
(17.41)
|
58.5
(16.97)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
31
36%
|
13
38.2%
|
12
36.4%
|
5
21.7%
|
61
34.7%
|
Male |
55
64%
|
21
61.8%
|
21
63.6%
|
18
78.3%
|
115
65.3%
|
Outcome Measures
Title | Number of Participants DLT in Arm 1 in Dose Escalation Phase |
---|---|
Description | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. |
Time Frame | Cycle 1 (28-day treatment cycle) |
Outcome Measure Data
Analysis Population Description |
---|
MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1. |
Arm/Group Title | Arm 1, Group X (20 mg) | Arm 1, Group X (30 mg) | Arm 1, Group X (40 mg) | Arm 1, Group X (60 mg) - MTD | Arm 1, Group X (80 mg) | Arm 1, Group Y (20 mg) | Arm 1, Group Y (30 mg) | Arm 1, Group Y (40 mg) - MTD | Arm 1, Group Y (60 mg) |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
Measure Participants | 7 | 6 | 8 | 12 | 6 | 1 | 3 | 15 | 4 |
Number [Participants] |
0
0%
|
0
0%
|
2
6.1%
|
1
4.3%
|
4
2.3%
|
0
NaN
|
0
NaN
|
5
NaN
|
4
NaN
|
Title | Number of Participants DLT in Arm 2 in Dose Escalation Phase |
---|---|
Description | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. |
Time Frame | Cycle 1 (28-day treamtent cycle) |
Outcome Measure Data
Analysis Population Description |
---|
MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat. |
Arm/Group Title | Arm 2, Group X (30 mg) | Arm 2, Group X (45 mg) | Arm 2, Group X (60 mg) | Arm 2, Group X (80 mg) | Arm 2, Group Y (30 mg) | Arm 2, Group Y (45 mg) | Arm 2, Group Y (60 mg) - MTD |
---|---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. |
Measure Participants | 6 | 7 | 7 | 8 | 1 | 6 | 13 |
Number [Participants] |
0
0%
|
0
0%
|
0
0%
|
4
17.4%
|
0
0%
|
0
NaN
|
3
NaN
|
Title | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) |
---|---|
Description | Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease. |
Time Frame | 3.5 years |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned. |
Arm/Group Title | Arm 1, Group X | Arm 2, Group X |
---|---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
Measure Participants | 59 | 24 |
Complete response (CR) |
2
2.3%
|
0
0%
|
Partial remission (PR) |
1
1.2%
|
1
2.9%
|
Stable disease (SD) |
25
29.1%
|
10
29.4%
|
Progressive disease (PD)/failure |
17
19.8%
|
4
11.8%
|
Not evaluable |
3
3.5%
|
1
2.9%
|
Missing |
11
12.8%
|
8
23.5%
|
Title | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase |
---|---|
Description | Stage 2 did not open for enrollment. |
Time Frame | 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease. |
Arm/Group Title | Arm 1, Group X |
---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
Measure Participants | 19 |
Complete response (CR) |
1
1.2%
|
Progressive disease (PD)/failure |
5
5.8%
|
Stable disease (SD) |
6
7%
|
Not evaluable |
2
2.3%
|
Missing |
5
5.8%
|
Title | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) |
---|---|
Description | Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure. |
Time Frame | 3.5 years |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | Arm 1, Group Y | Arm 2, Group Y |
---|---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. |
Measure Participants | 22 | 10 |
Complete response (CR) |
1
1.2%
|
1
2.9%
|
Partial remission (PR) |
4
4.7%
|
3
8.8%
|
Stable disease (SD) |
11
12.8%
|
4
11.8%
|
Progressive disease (PD)/failure |
1
1.2%
|
2
5.9%
|
Missing |
5
5.8%
|
0
0%
|
Title | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) |
---|---|
Description | Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission. |
Time Frame | 3.5 years |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | Arm 1, Group X | Arm 2, Group X |
---|---|---|
Arm/Group Description | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. |
Measure Participants | 9 | 2 |
Complete response (CR) |
0
0%
|
0
0%
|
Stable disease (SD) |
4
4.7%
|
1
2.9%
|
Progressive disease (PD)/failure |
4
4.7%
|
0
0%
|
Missing |
1
1.2%
|
0
0%
|
Partial remission (PR) |
0
0%
|
1
2.9%
|
Title | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 |
---|---|
Description | |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample. |
Arm/Group Title | 20 mg | 30 mg | 40 mg | 45 mg | 60 mg | 80 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 9 | 18 | 24 | 15 | 53 | 18 |
Mean (Standard Deviation) [ng/mL] |
19.5
(11.84)
|
39.8
(27.51)
|
58
(34.25)
|
54
(28.38)
|
66.9
(46.55)
|
63.5
(36.6)
|
Title | Half Life of Panobinostat After the First Dose in Arms 1 and 2 |
---|---|
Description | |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic set |
Arm/Group Title | 20 mg | 30 mg | 40 mg | 45 mg | 60 mg | 80 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 9 | 18 | 24 | 15 | 53 | 18 |
Mean (Standard Deviation) [hour] |
13.8
(6.65)
|
18.2
(5.47)
|
13.6
(3.26)
|
19.7
(11.68)
|
15.4
(4.14)
|
14.6
(2.6)
|
Title | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 |
---|---|
Description | From day 15 by dose with schedule: MWF every week |
Time Frame | Day 15 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic set |
Arm/Group Title | 20 mg | 30 mg | 40 mg | 60 mg | 80 mg |
---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 8 | 12 | 22 | 17 | 4 |
Mean (Standard Deviation) [ng/mL] |
33.6
(16.33)
|
38.4
(23.58)
|
41.6
(36.54)
|
51.8
(28.78)
|
69.6
(26.78)
|
Title | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 |
---|---|
Description | |
Time Frame | Day 15 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic set |
Arm/Group Title | 20 mg | 30 mg | 40 mg | 60 mg | 80 mg |
---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 8 | 12 | 22 | 17 | 4 |
Mean (Standard Deviation) [hour] |
20.1
(7.06)
|
19.7
(6.03)
|
21.4
(8.87)
|
17.9
(4.61)
|
17.7
(8.9)
|
Title | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 |
---|---|
Description | MWF Every week schedule n = number of subjects with non-missing values. |
Time Frame | Day 15/day 1 |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic set |
Arm/Group Title | 20 mg | 30 mg | 40 mg | 60 mg | 80 mg |
---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 8 | 12 | 18 | 17 | 4 |
AUC |
2.16
|
1.07
|
0.98
|
1.17
|
1.12
|
C (max) N=8,12,18,17,4 |
1.86
|
1.02
|
0.63
|
0.74
|
1.41
|
Title | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X |
---|---|
Description | Reporting the number of patients with a reading at the timepoint in the dose group. |
Time Frame | Days 1, 5, 8, 10, 15 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group. |
Arm/Group Title | Arm 1, Group X (20 mg) | Arm 1, Group X (30 mg) | Arm 1, Group X (40 mg) | Arm 1, Group X (60 mg) | Arm 1, Group X (80 mg) |
---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. |
Measure Participants | 8 | 8 | 10 | 49 | 11 |
Day 1 (total=0, 1, 0, 0, 0) |
NA
NaN
|
100.0
294.1%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
Day 5 (total = 6, 4, 8, 17, 8) |
100.0
116.3%
|
75.0
220.6%
|
87.5
265.2%
|
82.4
358.3%
|
37.5
21.3%
|
Day 8 (total = 5, 4, 8, 17, 7) |
100.0
116.3%
|
100.0
294.1%
|
75.0
227.3%
|
82.4
358.3%
|
57.1
32.4%
|
Day 10 (total=0, 0, 0, 0, 0, 1) |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
100.0
56.8%
|
Day 15 (total=3, 3, 4, 2, 2) |
66.7
77.6%
|
33.3
97.9%
|
50.0
151.5%
|
50.0
217.4%
|
50.0
28.4%
|
Title | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y |
---|---|
Description | |
Time Frame | Days 5, 8, end of study (up to 3.5 years) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | Arm 1, Group Y (20 mg) | Arm 1, Group Y (30 mg) | Arm 1, Group Y (40 mg) | Arm 1, Group Y (60 mg) |
---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 1 | 4 | 24 | 5 |
Day 5 (total= 1, 2, 15, 4) |
100.0
116.3%
|
100.0
294.1%
|
66.7
202.1%
|
75.0
326.1%
|
Day 8 (total = 1, 3, 11, 4) |
100.0
116.3%
|
100.0
294.1%
|
72.7
220.3%
|
75.0
326.1%
|
End of Study (total=1, 0, 0, 0) |
0.0
0%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
Title | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X |
---|---|
Description | |
Time Frame | Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | Arm 2, Group X (30 mg) | Arm 2, Group X (45 mg) | Arm 2, Group X (60 mg) | Arm 2, Group X (80 mg) |
---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 6 | 9 | 9 | 9 |
Day 5 (total=4, 9, 6, 8) |
50.0
58.1%
|
88.9
261.5%
|
83.3
252.4%
|
100.0
434.8%
|
Day 8 (total = 4, 7, 5, 7) |
50.0
58.1%
|
100.0
294.1%
|
80.0
242.4%
|
100.0
434.8%
|
Day 10 (Total=3, 8, 5, 7) |
33.3
38.7%
|
37.5
110.3%
|
80.0
242.4%
|
100.0
434.8%
|
Day 12 (Total=4, 6, 4, 8) |
25.0
29.1%
|
NA
NaN
|
50.0
151.5%
|
50.0
217.4%
|
Day 15 (Total=4, 6, 2, 5) |
75.0
87.2%
|
50.0
147.1%
|
100.0
303%
|
60.0
260.9%
|
End of Study (Total=1, 4, 2, 0) |
100.0
116.3%
|
75.0
220.6%
|
50.0
151.5%
|
0.0
0%
|
Unscheduled (Total=2, 0, 0, 0) |
50.0
58.1%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
Title | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y |
---|---|
Description | |
Time Frame | Days 5, 8, 10, 12, 15, End of study (up to 3.5 years) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set |
Arm/Group Title | Arm 2, Group Y (30 mg) | Arm 2, Group Y (45 mg) | Arm 2, Group Y (60 mg) |
---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) |
Measure Participants | 1 | 7 | 15 |
Day 5 (total=1, 4, 6) |
100.0
116.3%
|
100.0
294.1%
|
100.0
303%
|
Day 8 (total = 1, 4, 6) |
100.0
116.3%
|
100.0
294.1%
|
83.3
252.4%
|
Day 10 (total=1, 4, 5) |
NA
NaN
|
50.0
147.1%
|
60.0
181.8%
|
Day 12 (Total=0, 3, 5) |
NA
NaN
|
33.3
97.9%
|
40.0
121.2%
|
Day 15 (Total=1, 3, 5) |
100.0
116.3%
|
33.3
97.9%
|
0
0%
|
End of Study (Total=0, 2, 0) |
NA
NaN
|
50.0
147.1%
|
NA
NaN
|
Title | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) |
---|---|
Description | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) |
Time Frame | Post dose to pre-dose (up to 3.5 years) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (with available samples for analysis) |
Arm/Group Title | Arm 1, Group X (20 mg) | Arm 1, Group x (30 mg) | Arm 1, Group X (40 mg) | Arm 1, Group X (60 mg) | Arm 1, Group X (80 mg) | Arm 1, Group Y (20 mg) | Arm 1, Group Y (30 mg) | Arm 1, Group Y (40mg) | Arm 1, Group Y (60 mg) |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. |
Measure Participants | 8 | 4 | 7 | 21 | 8 | 1 | 4 | 16 | 5 |
Mean (Standard Deviation) [Percent Change] |
56.6
(97.26)
|
22.5
(45)
|
63.2
(87.21)
|
591.4
(2438.34)
|
31
(70.04)
|
66.7
(NA)
|
150.0
(125.59)
|
196.3
(193.25)
|
1998.5
(4250.04)
|
Title | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) |
---|---|
Description | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours])) |
Time Frame | Post dose to pre-dose (up to 3.5 years) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (with available samples for analysis) |
Arm/Group Title | Arm 2, Group X (30 mg) | Arm 2, Group X (45 mg) | Arm 2, Group X (60 mg) | Arm 2, Group X (80 mg) | Arm 2, Group Y (30 mg) | Arm 2, Group Y (45 mg) | Arm 2, Group Y (60 mg) |
---|---|---|---|---|---|---|---|
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. |
Measure Participants | 3 | 8 | 7 | 6 | 1 | 4 | 10 |
Mean (Standard Deviation) [Percent Change] |
96.2
(103.01)
|
67.7
(131.87)
|
59.3
(125.18)
|
34.2
(47.88)
|
0.0
(NA)
|
200.7
(210.73)
|
376.0
(540.27)
|
Adverse Events
Time Frame | AEs were collected for at least 4 weeks following last dose of treatment (3.5 years) | |||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||||||||||||||||||||||||
Arm/Group Title | Arm1, Group X (20 mg) | Arm1, Group X (30 mg) | Arm1, Group X (40 mg) | Arm1 GroupX 60 mg | Arm1 GroupX 80 mg | Arm1 GroupY 20 mg | Arm1 GroupY 30 mg | Arm1 GroupY 40 mg | Arm1 GroupY 60 mg | Arm2 GroupX 30 mg | Arm2 GroupX 45 mg | Arm2 GroupX 60 mg | Arm2 GroupX 80 mg | Arm2 GroupY 30 mg | Arm2 GroupY 45 mg | Arm2 GroupY 60 mg | ||||||||||||||||
Arm/Group Description | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | ||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||
Arm1, Group X (20 mg) | Arm1, Group X (30 mg) | Arm1, Group X (40 mg) | Arm1 GroupX 60 mg | Arm1 GroupX 80 mg | Arm1 GroupY 20 mg | Arm1 GroupY 30 mg | Arm1 GroupY 40 mg | Arm1 GroupY 60 mg | Arm2 GroupX 30 mg | Arm2 GroupX 45 mg | Arm2 GroupX 60 mg | Arm2 GroupX 80 mg | Arm2 GroupY 30 mg | Arm2 GroupY 45 mg | Arm2 GroupY 60 mg | |||||||||||||||||
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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||
Arm1, Group X (20 mg) | Arm1, Group X (30 mg) | Arm1, Group X (40 mg) | Arm1 GroupX 60 mg | Arm1 GroupX 80 mg | Arm1 GroupY 20 mg | Arm1 GroupY 30 mg | Arm1 GroupY 40 mg | Arm1 GroupY 60 mg | Arm2 GroupX 30 mg | Arm2 GroupX 45 mg | Arm2 GroupX 60 mg | Arm2 GroupX 80 mg | Arm2 GroupY 30 mg | Arm2 GroupY 45 mg | Arm2 GroupY 60 mg | |||||||||||||||||
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 | 8/8 (100%) | 5/8 (62.5%) | 9/10 (90%) | 34/49 (69.4%) | 10/11 (90.9%) | 0/1 (0%) | 3/4 (75%) | 10/24 (41.7%) | 2/5 (40%) | 5/6 (83.3%) | 8/9 (88.9%) | 7/9 (77.8%) | 8/9 (88.9%) | 0/1 (0%) | 3/7 (42.9%) | 11/15 (73.3%) | ||||||||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||
Anaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 2/4 (50%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Febrile neutropenia | 4/8 (50%) | 0/8 (0%) | 4/10 (40%) | 12/49 (24.5%) | 4/11 (36.4%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 2/5 (40%) | 2/6 (33.3%) | 3/9 (33.3%) | 3/9 (33.3%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Leukocytosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Neutropenia | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Thrombocytopenia | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 2/9 (22.2%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cardiac disorders | ||||||||||||||||||||||||||||||||
Acute myocardial infarction | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Atrial fibrillation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Atrial flutter | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cardiac failure | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Cardiac failure congestive | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Cardiomyopathy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sinus tachycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Supraventricular tachycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tachycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Ear and labyrinth disorders | ||||||||||||||||||||||||||||||||
Vertigo positional | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastrointestinal disorders | ||||||||||||||||||||||||||||||||
Abdominal distension | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Abdominal pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Abdominal pain upper | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Constipation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Diarrhoea | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Diarrhoea haemorrhagic | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Femoral hernia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastritis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nausea | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pancreatitis acute | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Rectal haemorrhage | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Umbilical hernia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vomiting | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
General disorders | ||||||||||||||||||||||||||||||||
Catheter related complication | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Chest pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Condition aggravated | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Disease progression | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fatigue | 3/8 (37.5%) | 0/8 (0%) | 4/10 (40%) | 3/49 (6.1%) | 3/11 (27.3%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
General physical health deterioration | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Generalised oedema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Multi-organ failure | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pyrexia | 0/8 (0%) | 0/8 (0%) | 2/10 (20%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 2/9 (22.2%) | 1/9 (11.1%) | 3/9 (33.3%) | 0/1 (0%) | 1/7 (14.3%) | 3/15 (20%) | ||||||||||||||||
Hepatobiliary disorders | ||||||||||||||||||||||||||||||||
Bile duct stone | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cholangitis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cholecystitis acute | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperbilirubinaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||||||
Alpha haemolytic streptococcal infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Arthritis viral | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Bacteraemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bacterial infection | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bacterial sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bronchopulmonary aspergillosis | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Catheter related infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Catheter sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Cellulitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Clostridium difficile colitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Enterococcal sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Escherichia infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastroenteritis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Influenza | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lower respiratory tract infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Necrotising fasciitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Neutropenic infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Neutropenic sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Penile abscess | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Perirectal abscess | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pharyngitis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pneumonia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Pneumonia fungal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pseudomonas infection | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sepsis | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 1/5 (20%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Septic shock | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Serratia infection | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sinusitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Staphylococcal bacteraemia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Staphylococcal infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urinary tract infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||
Drug toxicity | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hip fracture | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Lower limb fracture | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Meniscus lesion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Transfusion reaction | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Transfusion-related circulatory overload | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Investigations | ||||||||||||||||||||||||||||||||
Blood creatinine increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cardiac electrophysiologic study abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram T wave abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lipase increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Liver function test abnormal | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Troponin I increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Troponin increased | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||
Anorexia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dehydration | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Failure to thrive | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fluid imbalance | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperuricaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypokalaemia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyponatraemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||
Arthralgia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Arthritis reactive | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Back pain | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bone pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Chondrocalcinosis pyrophosphate | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Musculoskeletal pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Myofascitis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||
Leukaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Leukaemic infiltration brain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Leukostasis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Squamous cell carcinoma of skin | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tumour lysis syndrome | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nervous system disorders | ||||||||||||||||||||||||||||||||
Cerebral haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cerebral ischaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cerebrovascular accident | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cognitive disorder | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Convulsion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Depressed level of consciousness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dizziness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Headache | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lethargy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Leukoencephalopathy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Syncope | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal and urinary disorders | ||||||||||||||||||||||||||||||||
Nephrolithiasis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Renal failure | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal failure acute | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal impairment | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||
Dyspareunia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||
Cough | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Diffuse alveolar damage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Dyspnoea | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Epistaxis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haemoptysis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypoxia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Obstructive airways disorder | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pleural effusion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pulmonary haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pulmonary oedema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Respiratory failure | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tachypnoea | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Surgical and medical procedures | ||||||||||||||||||||||||||||||||
Abortion induced | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Catheter removal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Vascular disorders | ||||||||||||||||||||||||||||||||
Hypotension | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||
Arm1, Group X (20 mg) | Arm1, Group X (30 mg) | Arm1, Group X (40 mg) | Arm1 GroupX 60 mg | Arm1 GroupX 80 mg | Arm1 GroupY 20 mg | Arm1 GroupY 30 mg | Arm1 GroupY 40 mg | Arm1 GroupY 60 mg | Arm2 GroupX 30 mg | Arm2 GroupX 45 mg | Arm2 GroupX 60 mg | Arm2 GroupX 80 mg | Arm2 GroupY 30 mg | Arm2 GroupY 45 mg | Arm2 GroupY 60 mg | |||||||||||||||||
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 | 8/8 (100%) | 8/8 (100%) | 10/10 (100%) | 49/49 (100%) | 11/11 (100%) | 1/1 (100%) | 4/4 (100%) | 24/24 (100%) | 5/5 (100%) | 6/6 (100%) | 9/9 (100%) | 9/9 (100%) | 9/9 (100%) | 1/1 (100%) | 7/7 (100%) | 15/15 (100%) | ||||||||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||
Anaemia | 3/8 (37.5%) | 3/8 (37.5%) | 1/10 (10%) | 22/49 (44.9%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 9/24 (37.5%) | 1/5 (20%) | 0/6 (0%) | 3/9 (33.3%) | 4/9 (44.4%) | 2/9 (22.2%) | 0/1 (0%) | 2/7 (28.6%) | 7/15 (46.7%) | ||||||||||||||||
Bone marrow failure | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Coagulopathy | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Febrile neutropenia | 4/8 (50%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypoprothrombinaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Leukocytosis | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 6/49 (12.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Leukopenia | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Lymphadenopathy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Neutropenia | 0/8 (0%) | 2/8 (25%) | 2/10 (20%) | 18/49 (36.7%) | 2/11 (18.2%) | 1/1 (100%) | 2/4 (50%) | 8/24 (33.3%) | 2/5 (40%) | 0/6 (0%) | 2/9 (22.2%) | 4/9 (44.4%) | 6/9 (66.7%) | 0/1 (0%) | 2/7 (28.6%) | 6/15 (40%) | ||||||||||||||||
Pancytopenia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Splenic infarction | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Splenomegaly | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Spontaneous haematoma | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Thrombocytopenia | 2/8 (25%) | 3/8 (37.5%) | 4/10 (40%) | 26/49 (53.1%) | 3/11 (27.3%) | 1/1 (100%) | 4/4 (100%) | 22/24 (91.7%) | 5/5 (100%) | 1/6 (16.7%) | 3/9 (33.3%) | 3/9 (33.3%) | 6/9 (66.7%) | 1/1 (100%) | 4/7 (57.1%) | 11/15 (73.3%) | ||||||||||||||||
Cardiac disorders | ||||||||||||||||||||||||||||||||
Aortic valve incompetence | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Atrial fibrillation | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Atrial flutter | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Atrioventricular block | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Atrioventricular block second degree | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bradycardia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cardiac disorder | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cardiac failure | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Cardiovascular disorder | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Coronary artery disease | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dilatation ventricular | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Left ventricular dysfunction | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Palpitations | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sinus bradycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Sinus tachycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Supraventricular extrasystoles | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Supraventricular tachycardia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tachyarrhythmia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tachycardia | 0/8 (0%) | 2/8 (25%) | 1/10 (10%) | 6/49 (12.2%) | 3/11 (27.3%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Ventricular arrhythmia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ventricular extrasystoles | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Congenital, familial and genetic disorders | ||||||||||||||||||||||||||||||||
Antithrombin III deficiency | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ear and labyrinth disorders | ||||||||||||||||||||||||||||||||
Deafness | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Deafness bilateral | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hearing impaired | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperacusis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vertigo | 0/8 (0%) | 1/8 (12.5%) | 2/10 (20%) | 5/49 (10.2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Endocrine disorders | ||||||||||||||||||||||||||||||||
Cushingoid | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Goitre | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperparathyroidism secondary | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hyperthyroidism | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypothyroidism | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Thyroid disorder | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Eye disorders | ||||||||||||||||||||||||||||||||
Conjunctivitis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Diplopia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Eye irritation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyphaema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Keratoconjunctivitis sicca | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Lacrimation increased | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Ocular hyperaemia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ocular icterus | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pupillary disorder | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Visual Impairment | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Visual disturbance | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastrointestinal disorders | ||||||||||||||||||||||||||||||||
Abdominal discomfort | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Abdominal distension | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Abdominal pain | 2/8 (25%) | 2/8 (25%) | 3/10 (30%) | 16/49 (32.7%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 7/24 (29.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 3/9 (33.3%) | 0/1 (0%) | 0/7 (0%) | 3/15 (20%) | ||||||||||||||||
Abdominal pain lower | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Abdominal pain upper | 0/8 (0%) | 0/8 (0%) | 2/10 (20%) | 5/49 (10.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Anal discomfort | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Anal haemorrhage | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ascites | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Caecitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Constipation | 2/8 (25%) | 0/8 (0%) | 1/10 (10%) | 13/49 (26.5%) | 3/11 (27.3%) | 0/1 (0%) | 1/4 (25%) | 7/24 (29.2%) | 0/5 (0%) | 2/6 (33.3%) | 2/9 (22.2%) | 4/9 (44.4%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 5/15 (33.3%) | ||||||||||||||||
Diarrhoea | 5/8 (62.5%) | 5/8 (62.5%) | 5/10 (50%) | 41/49 (83.7%) | 10/11 (90.9%) | 0/1 (0%) | 3/4 (75%) | 15/24 (62.5%) | 1/5 (20%) | 3/6 (50%) | 4/9 (44.4%) | 6/9 (66.7%) | 5/9 (55.6%) | 1/1 (100%) | 5/7 (71.4%) | 10/15 (66.7%) | ||||||||||||||||
Dry mouth | 0/8 (0%) | 1/8 (12.5%) | 2/10 (20%) | 6/49 (12.2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 6/24 (25%) | 0/5 (0%) | 0/6 (0%) | 2/9 (22.2%) | 1/9 (11.1%) | 2/9 (22.2%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Dyspepsia | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 2/9 (22.2%) | 2/9 (22.2%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Dysphagia | 2/8 (25%) | 1/8 (12.5%) | 0/10 (0%) | 7/49 (14.3%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 2/7 (28.6%) | 1/15 (6.7%) | ||||||||||||||||
Epigastric discomfort | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Eructation | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Faecal incontinence | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Flatulence | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastric ulcer | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gastritis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Gastritis atrophic | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Gastrooesophageal reflux disease | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gingival bleeding | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 2/9 (22.2%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gingival disorder | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gingivitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Glossodynia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Haematemesis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haematochezia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haemorrhoids | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Impaired gastric emptying | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lip haemorrhage | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Melaena | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Mouth haemorrhage | 2/8 (25%) | 2/8 (25%) | 2/10 (20%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Mouth ulceration | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 5/49 (10.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 3/6 (50%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Nausea | 5/8 (62.5%) | 5/8 (62.5%) | 9/10 (90%) | 31/49 (63.3%) | 8/11 (72.7%) | 0/1 (0%) | 1/4 (25%) | 16/24 (66.7%) | 3/5 (60%) | 4/6 (66.7%) | 3/9 (33.3%) | 7/9 (77.8%) | 7/9 (77.8%) | 1/1 (100%) | 6/7 (85.7%) | 12/15 (80%) | ||||||||||||||||
Odynophagia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Oesophageal pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oral discomfort | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oral disorder | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oral mucosal petechiae | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oral pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 6/49 (12.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Pancreatic calcification | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Proctalgia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Rectal haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Reflux oesophagitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Saliva altered | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Stomatitis | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 2/9 (22.2%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Stomatitis haemorrhagic | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tongue coated | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tongue discolouration | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Toothache | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Varices oesophageal | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vomiting | 4/8 (50%) | 2/8 (25%) | 8/10 (80%) | 23/49 (46.9%) | 6/11 (54.5%) | 0/1 (0%) | 0/4 (0%) | 9/24 (37.5%) | 1/5 (20%) | 2/6 (33.3%) | 1/9 (11.1%) | 5/9 (55.6%) | 4/9 (44.4%) | 1/1 (100%) | 5/7 (71.4%) | 7/15 (46.7%) | ||||||||||||||||
General disorders | ||||||||||||||||||||||||||||||||
Catheter related complication | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Catheter site haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Catheter site oedema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Catheter site pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Catheter site related reaction | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Chest pain | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 5/49 (10.2%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Chills | 0/8 (0%) | 1/8 (12.5%) | 4/10 (40%) | 15/49 (30.6%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 3/15 (20%) | ||||||||||||||||
Chronic fatigue syndrome | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cyst | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Face oedema | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fatigue | 3/8 (37.5%) | 5/8 (62.5%) | 7/10 (70%) | 36/49 (73.5%) | 8/11 (72.7%) | 1/1 (100%) | 1/4 (25%) | 19/24 (79.2%) | 3/5 (60%) | 3/6 (50%) | 6/9 (66.7%) | 4/9 (44.4%) | 5/9 (55.6%) | 0/1 (0%) | 6/7 (85.7%) | 12/15 (80%) | ||||||||||||||||
Feeling cold | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Gait disturbance | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
General physical health deterioration | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hyperthermia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypothermia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Inflammation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Influenza like illness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Local swelling | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Malaise | 0/8 (0%) | 0/8 (0%) | 2/10 (20%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Mass | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Mucosal haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Mucosal inflammation | 3/8 (37.5%) | 3/8 (37.5%) | 2/10 (20%) | 2/49 (4.1%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Non-cardiac chest pain | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 1/1 (100%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Oedema mucosal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oedema peripheral | 3/8 (37.5%) | 2/8 (25%) | 4/10 (40%) | 16/49 (32.7%) | 4/11 (36.4%) | 0/1 (0%) | 2/4 (50%) | 6/24 (25%) | 1/5 (20%) | 1/6 (16.7%) | 2/9 (22.2%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 3/7 (42.9%) | 3/15 (20%) | ||||||||||||||||
Pain | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Pitting oedema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pyrexia | 1/8 (12.5%) | 4/8 (50%) | 2/10 (20%) | 16/49 (32.7%) | 3/11 (27.3%) | 0/1 (0%) | 1/4 (25%) | 5/24 (20.8%) | 2/5 (40%) | 2/6 (33.3%) | 4/9 (44.4%) | 4/9 (44.4%) | 2/9 (22.2%) | 0/1 (0%) | 3/7 (42.9%) | 4/15 (26.7%) | ||||||||||||||||
Sensation of blood flow | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Thirst decreased | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hepatobiliary disorders | ||||||||||||||||||||||||||||||||
Cholelithiasis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hepatic cyst | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hepatic failure | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hepatic function abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hepatomegaly | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperbilirubinaemia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 1/5 (20%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Immune system disorders | ||||||||||||||||||||||||||||||||
Immunodeficiency | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Seasonal allergy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||||||
Anal abscess | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Anal candidiasis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Aspergillosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bacterial infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bronchitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Candida pneumonia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Candidiasis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Catheter related infection | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Catheter sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Cellulitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Clostridium difficile colitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Condyloma acuminatum | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Conjunctivitis bacterial | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Enterobacter bacteraemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Enterobacter infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Enterococcal bacteraemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Enterococcal infection | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Enterococcal sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Escherichia infection | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Folliculitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Gastroenteritis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Herpes simplex | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Herpes virus infection | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Infection | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Klebsiella bacteraemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Klebsiella sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lower respiratory tract infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 2/4 (50%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Micrococcal sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nasopharyngitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Oesophageal candidiasis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Oral candidiasis | 2/8 (25%) | 0/8 (0%) | 1/10 (10%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 2/9 (22.2%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Osteomyelitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Otitis externa | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Paronychia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pharyngitis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pilonidal cyst | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pneumonia | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Pneumonia fungal | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pseudomonal bacteraemia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pseudomonal sepsis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pseudomonas infection | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Rash pustular | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Respiratory tract infection | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 1/1 (100%) | 2/4 (50%) | 5/24 (20.8%) | 1/5 (20%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 3/15 (20%) | ||||||||||||||||
Rhinitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 1/1 (100%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sinusitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Staphylococcal infection | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Staphylococcal sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Streptococcal sepsis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tracheitis | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urinary tract infection | 2/8 (25%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 2/9 (22.2%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Viral infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vulvovaginal mycotic infection | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||
Arthropod bite | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Contusion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Excoriation | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fall | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haemothorax | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Open wound | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Post procedural oedema | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Procedural pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Scratch | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin injury | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin laceration | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tooth fracture | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Transfusion reaction | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Investigations | ||||||||||||||||||||||||||||||||
Activated partial thromboplastin time shortened | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Alanine aminotransferase increased | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Anaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Anti-erythrocyte antibody positive | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Antithrombin III decreased | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Aspartate aminotransferase increased | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Aspiration biopsy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Biopsy skin | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Blood albumin decreased | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood alkaline phosphatase increased | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Blood bicarbonate decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood bilirubin increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood calcium decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood creatine phosphokinase increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Blood creatinine increased | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 10/49 (20.4%) | 4/11 (36.4%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 4/15 (26.7%) | ||||||||||||||||
Blood fibrinogen increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood glucose increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Blood lactate dehydrogenase increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood magnesium decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood sodium increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood thyroid stimulating hormone increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 3/15 (20%) | ||||||||||||||||
Blood triglycerides increased | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood urea increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Blood uric acid increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Breath sounds abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
C-reactive protein increased | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 7/49 (14.3%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 4/15 (26.7%) | ||||||||||||||||
Clostridium difficile toxin test positive | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Computerised tomogram abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ejection fraction decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram QRS complex prolonged | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram QT corrected interval prolonged | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram QT prolonged | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 4/11 (36.4%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram ST segment abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Electrocardiogram ST segment depression | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram ST-T change | 0/8 (0%) | 1/8 (12.5%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Electrocardiogram T wave abnormal | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrocardiogram repolarisation abnormality | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fibrin D dimer increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fungus stool identified | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gamma-glutamyltransferase increased | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Glomerular filtration rate decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypophosphataemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
International normalised ratio increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Liver function test abnormal | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oxygen saturation decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Oxygen saturation increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Prostatic specific antigen increased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Prothrombin time prolonged | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Prothrombin time shortened | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Red blood cells urine positive | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Transaminases increased | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Troponin increased | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urine output decreased | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Weight decreased | 3/8 (37.5%) | 3/8 (37.5%) | 3/10 (30%) | 17/49 (34.7%) | 4/11 (36.4%) | 0/1 (0%) | 0/4 (0%) | 11/24 (45.8%) | 0/5 (0%) | 2/6 (33.3%) | 2/9 (22.2%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 3/7 (42.9%) | 3/15 (20%) | ||||||||||||||||
Weight increased | 0/8 (0%) | 0/8 (0%) | 2/10 (20%) | 4/49 (8.2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||
Anorexia | 5/8 (62.5%) | 4/8 (50%) | 6/10 (60%) | 32/49 (65.3%) | 6/11 (54.5%) | 0/1 (0%) | 1/4 (25%) | 10/24 (41.7%) | 1/5 (20%) | 2/6 (33.3%) | 1/9 (11.1%) | 3/9 (33.3%) | 3/9 (33.3%) | 0/1 (0%) | 4/7 (57.1%) | 8/15 (53.3%) | ||||||||||||||||
Dehydration | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 9/49 (18.4%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 3/9 (33.3%) | 2/9 (22.2%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Electrolyte imbalance | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Fluid overload | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Folate deficiency | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Gout | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypercalcaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Hyperglycaemia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Hyperkalaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 5/49 (10.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 4/15 (26.7%) | ||||||||||||||||
Hypermagnesaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Hyperphosphataemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperuricaemia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Hypoalbuminaemia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hypocalcaemia | 4/8 (50%) | 1/8 (12.5%) | 2/10 (20%) | 17/49 (34.7%) | 6/11 (54.5%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 1/9 (11.1%) | 4/9 (44.4%) | 0/1 (0%) | 1/7 (14.3%) | 4/15 (26.7%) | ||||||||||||||||
Hypoglycaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Hypokalaemia | 4/8 (50%) | 5/8 (62.5%) | 1/10 (10%) | 21/49 (42.9%) | 7/11 (63.6%) | 0/1 (0%) | 1/4 (25%) | 8/24 (33.3%) | 3/5 (60%) | 2/6 (33.3%) | 1/9 (11.1%) | 2/9 (22.2%) | 3/9 (33.3%) | 0/1 (0%) | 2/7 (28.6%) | 4/15 (26.7%) | ||||||||||||||||
Hypomagnesaemia | 1/8 (12.5%) | 1/8 (12.5%) | 1/10 (10%) | 6/49 (12.2%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 2/24 (8.3%) | 2/5 (40%) | 2/6 (33.3%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyponatraemia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 7/49 (14.3%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hypophagia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypophosphataemia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 9/49 (18.4%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 2/5 (40%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 3/9 (33.3%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Iron overload | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Malnutrition | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Metabolic alkalosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Podagra | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vitamin B6 deficiency | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vitamin D deficiency | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||||
Arthralgia | 0/8 (0%) | 1/8 (12.5%) | 2/10 (20%) | 2/49 (4.1%) | 3/11 (27.3%) | 1/1 (100%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) | 1/1 (100%) | 0/7 (0%) | 4/15 (26.7%) | ||||||||||||||||
Arthritis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Back pain | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 9/49 (18.4%) | 3/11 (27.3%) | 1/1 (100%) | 0/4 (0%) | 5/24 (20.8%) | 0/5 (0%) | 1/6 (16.7%) | 3/9 (33.3%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 2/15 (13.3%) | ||||||||||||||||
Bone disorder | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bone pain | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Joint effusion | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Joint swelling | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Muscle spasms | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 5/15 (33.3%) | ||||||||||||||||
Muscular weakness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Musculoskeletal chest pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 2/4 (50%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 1/1 (100%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Musculoskeletal discomfort | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Musculoskeletal pain | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Myalgia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Neck pain | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Osteoarthritis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Osteonecrosis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pain in extremity | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 2/9 (22.2%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Pain in jaw | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pathological fracture | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Periostitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Polyarthritis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Shoulder pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 1/1 (100%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Spinal osteoarthritis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Synovial cyst | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||
Acute myeloid leukaemia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Seborrhoeic keratosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tumour lysis syndrome | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nervous system disorders | ||||||||||||||||||||||||||||||||
Ageusia | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 2/9 (22.2%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Aphasia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Balance disorder | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Carpal tunnel syndrome | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Coma | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Convulsion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Coordination abnormal | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Depressed level of consciousness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dizziness | 2/8 (25%) | 0/8 (0%) | 3/10 (30%) | 7/49 (14.3%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 1/5 (20%) | 2/6 (33.3%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dysarthria | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dysgeusia | 0/8 (0%) | 4/8 (50%) | 2/10 (20%) | 18/49 (36.7%) | 5/11 (45.5%) | 0/1 (0%) | 1/4 (25%) | 5/24 (20.8%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 1/9 (11.1%) | 2/9 (22.2%) | 0/1 (0%) | 2/7 (28.6%) | 5/15 (33.3%) | ||||||||||||||||
Facial palsy | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Headache | 1/8 (12.5%) | 1/8 (12.5%) | 3/10 (30%) | 10/49 (20.4%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 4/24 (16.7%) | 1/5 (20%) | 1/6 (16.7%) | 2/9 (22.2%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 6/15 (40%) | ||||||||||||||||
Hemiplegia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypoaesthesia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypokinesia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lethargy | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 2/11 (18.2%) | 0/1 (0%) | 1/4 (25%) | 3/24 (12.5%) | 1/5 (20%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 2/15 (13.3%) | ||||||||||||||||
Meningeal disorder | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Monoparesis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Paraesthesia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Parkinson's disease | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Peripheral paralysis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Peripheral sensory neuropathy | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Polyneuropathy | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sensory disturbance | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Sensory loss | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Somnolence | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Speech disorder | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Syncope | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Tremor | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Psychiatric disorders | ||||||||||||||||||||||||||||||||
Agitation | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Anxiety | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 5/49 (10.2%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) | 0/1 (0%) | 1/7 (14.3%) | 2/15 (13.3%) | ||||||||||||||||
Confusional state | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 4/49 (8.2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 2/9 (22.2%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Depressed mood | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Depression | 0/8 (0%) | 1/8 (12.5%) | 2/10 (20%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Disorientation | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hallucination | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Insomnia | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 11/49 (22.4%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 1/5 (20%) | 1/6 (16.7%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 2/7 (28.6%) | 1/15 (6.7%) | ||||||||||||||||
Mood altered | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nightmare | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Restlessness | 0/8 (0%) | 0/8 (0%) | 2/10 (20%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Sleep disorder | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal and urinary disorders | ||||||||||||||||||||||||||||||||
Anuria | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Bladder spasm | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Calculus ureteric | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Dysuria | 2/8 (25%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haematuria | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Incontinence | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Ketonuria | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Nocturia | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pollakiuria | 0/8 (0%) | 2/8 (25%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Polyuria | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Proteinuria | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal failure | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal failure acute | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 1/6 (16.7%) | 0/9 (0%) | 2/9 (22.2%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Renal impairment | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urethral pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urinary incontinence | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Urinary retention | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Reproductive system and breast disorders | ||||||||||||||||||||||||||||||||
Benign prostatic hyperplasia | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Breast swelling | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Metrorrhagia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pelvic pain | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Penile pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Prostatitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||
Acute pulmonary oedema | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Cough | 2/8 (25%) | 2/8 (25%) | 5/10 (50%) | 12/49 (24.5%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 7/24 (29.2%) | 2/5 (40%) | 0/6 (0%) | 2/9 (22.2%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 2/7 (28.6%) | 5/15 (33.3%) | ||||||||||||||||
Dysphonia | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dyspnoea | 4/8 (50%) | 3/8 (37.5%) | 4/10 (40%) | 11/49 (22.4%) | 6/11 (54.5%) | 0/1 (0%) | 0/4 (0%) | 4/24 (16.7%) | 1/5 (20%) | 1/6 (16.7%) | 4/9 (44.4%) | 0/9 (0%) | 3/9 (33.3%) | 0/1 (0%) | 2/7 (28.6%) | 4/15 (26.7%) | ||||||||||||||||
Dyspnoea exacerbated | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dyspnoea exertional | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Emphysema | 1/8 (12.5%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Epistaxis | 3/8 (37.5%) | 0/8 (0%) | 1/10 (10%) | 12/49 (24.5%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 6/24 (25%) | 1/5 (20%) | 2/6 (33.3%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 1/1 (100%) | 0/7 (0%) | 3/15 (20%) | ||||||||||||||||
Haemoptysis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hiccups | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hyperventilation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypocapnia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hypoxia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 1/15 (6.7%) | ||||||||||||||||
Lung consolidation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Lung infiltration | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Nasal dryness | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Painful respiration | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pharyngeal haemorrhage | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pharyngolaryngeal pain | 1/8 (12.5%) | 1/8 (12.5%) | 2/10 (20%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 3/24 (12.5%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Pleural effusion | 1/8 (12.5%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 3/11 (27.3%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pleuritic pain | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pneumonitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pneumothorax | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Productive cough | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Pulmonary congestion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pulmonary fibrosis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pulmonary oedema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Rales | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Respiratory acidosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 0/15 (0%) | ||||||||||||||||
Respiratory alkalosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Respiratory distress | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 1/4 (25%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Respiratory gas exchange disorder | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Rhinorrhoea | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Rhonchi | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Sinus congestion | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Tachypnoea | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Wheezing | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||
Alopecia | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 2/11 (18.2%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Blood blister | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Decubitus ulcer | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dermatitis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dermatitis acneiform | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Dry skin | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 3/49 (6.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Ecchymosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Eczema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 2/49 (4.1%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Erythema | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hyperhidrosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 4/49 (8.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Ingrowing nail | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Night sweats | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 4/49 (8.2%) | 1/11 (9.1%) | 0/1 (0%) | 1/4 (25%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 3/15 (20%) | ||||||||||||||||
Petechiae | 4/8 (50%) | 0/8 (0%) | 1/10 (10%) | 8/49 (16.3%) | 4/11 (36.4%) | 0/1 (0%) | 0/4 (0%) | 2/24 (8.3%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Pruritus | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 3/49 (6.1%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/1 (0%) | 1/7 (14.3%) | 2/15 (13.3%) | ||||||||||||||||
Rash | 2/8 (25%) | 1/8 (12.5%) | 2/10 (20%) | 6/49 (12.2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 2/9 (22.2%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 2/15 (13.3%) | ||||||||||||||||
Rash erythematous | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Rash generalised | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Rash pruritic | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Scab | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin discolouration | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin disorder | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Skin exfoliation | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin fissures | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin lesion | 0/8 (0%) | 2/8 (25%) | 1/10 (10%) | 2/49 (4.1%) | 0/11 (0%) | 1/1 (100%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Skin ulcer | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Subcutaneous emphysema | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Vascular disorders | ||||||||||||||||||||||||||||||||
Deep vein thrombosis | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Flushing | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Haematoma | 1/8 (12.5%) | 0/8 (0%) | 2/10 (20%) | 6/49 (12.2%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Hypertension | 1/8 (12.5%) | 1/8 (12.5%) | 2/10 (20%) | 2/49 (4.1%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Hypotension | 2/8 (25%) | 2/8 (25%) | 1/10 (10%) | 8/49 (16.3%) | 2/11 (18.2%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | 1/9 (11.1%) | 0/9 (0%) | 0/1 (0%) | 1/7 (14.3%) | 3/15 (20%) | ||||||||||||||||
Lymphoedema | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Orthostatic hypertension | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 1/11 (9.1%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Orthostatic hypotension | 0/8 (0%) | 0/8 (0%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 1/15 (6.7%) | ||||||||||||||||
Phlebitis | 1/8 (12.5%) | 0/8 (0%) | 0/10 (0%) | 1/49 (2%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Thrombophlebitis | 0/8 (0%) | 0/8 (0%) | 1/10 (10%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 1/24 (4.2%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) | ||||||||||||||||
Venoocclusive disease | 0/8 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/49 (0%) | 0/11 (0%) | 0/1 (0%) | 0/4 (0%) | 0/24 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) | 0/1 (0%) | 0/7 (0%) | 0/15 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the polled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 862-778-8300 |
- CLBH589B2102
- 2005-003670-26