Trial Outcomes & Findings for Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL (NCT NCT01722487)
NCT ID: NCT01722487
Last Updated: 2017-11-30
Results Overview
The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS Progressive disease according to 2008 IWCLL guidelines was defined as: * Group A * Lymphadenopathy, increase ≥50% * Hepatomegaly, increase ≥50% * Splenomegaly, increase ≥50% * Blood lymphocytes, increase ≥ 50% over baseline * Group B * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL * Hemoglobin, decrease of \> 2 g/dL from baseline secondary to CLL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Results posted on
2017-11-30
Participant Flow
Participant milestones
| Measure |
Ibrutinib
Ibrutinib 420 mg daily.
|
Chlorambucil
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
133
|
|
Overall Study
COMPLETED
|
134
|
126
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
136 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 5.67 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 5.95 • n=7 Participants
|
73.3 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Intention to treat
The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS Progressive disease according to 2008 IWCLL guidelines was defined as: * Group A * Lymphadenopathy, increase ≥50% * Hepatomegaly, increase ≥50% * Splenomegaly, increase ≥50% * Blood lymphocytes, increase ≥ 50% over baseline * Group B * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL * Hemoglobin, decrease of \> 2 g/dL from baseline secondary to CLL
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
PFS (Progression Free Survival)
|
NA Months
IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.
|
18.9 Months
Interval 14.1 to 22.0
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Intention to treat
OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
IBR: Median OS was not reached so 95% CI for median OS is not applicable.
|
NA Months
CHL: Median OS was not reached so 95% CI for median OS is not applicable.
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Intention to treat
ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
ORR (Overall Response Rate)
|
82.4 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Intention to treat
The proportion of subjects who achieved Hemoglobin \>11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
Proportion of Sustained Hemoglobin Improvement
|
45.6 Percentage of Participants
|
20.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Subjects with Baseline Anemia
In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin \>11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.
Outcome measures
| Measure |
Ibrutinib
n=51 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=55 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia
|
84.3 Percentage of Participants
|
45.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Intention to treat
The proportion of subjects who achieved platelet \>100 x 10\^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.
Outcome measures
| Measure |
Ibrutinib
n=136 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=133 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
Proportion of Sustained Platelet Improvement
|
27.2 Percentage of Participants
|
11.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.Population: Subjects With Baseline Thrombocytopenia
In randomized subjects with baseline platelet ≤ 100 x 10\^9/L, the proportion of subjects who achieved platelet \>100 x 10\^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.
Outcome measures
| Measure |
Ibrutinib
n=35 Participants
Ibrutinib 420 mg daily.
|
Chlorambucil
n=28 Participants
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
|
|---|---|---|
|
Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia
|
77.1 Percentage of Participants
|
42.9 Percentage of Participants
|
Adverse Events
PCI-32765
Serious events: 55 serious events
Other events: 133 other events
Deaths: 0 deaths
Chlorambucil
Serious events: 33 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI-32765
n=135 participants at risk
Ibrutinib 420 mg daily.
|
Chlorambucil
n=132 participants at risk
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Atrial flutter
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Aortic valve disease
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Blindness unilateral
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Hyphaema
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Retinal vascular occlusion
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Retinal vein occlusion
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Vitreous haemorrhage
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Death
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Oedema peripheral
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Pyrexia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Chills
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Pain
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Immune system disorders
Immunodeficiency
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Pneumonia
|
3.7%
5/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Bronchopneumonia
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Escherichia sepsis
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Abscess limb
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Anal abscess
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Arthritis bacterial
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Cellulitis
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Clostridium difficile infection
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Escherichia infection
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Klebsiella infection
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Lobar pneumonia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Neutropenic sepsis
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Pneumonia legionella
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Pneumonia viral
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Viral infection
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Investigations
Heart rate irregular
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
3/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.7%
5/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Headache
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Psychiatric disorders
Confusional state
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Psychiatric disorders
Somatoform disorder cardiovascular
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.74%
1/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Vascular disorders
Hypertension
|
1.5%
2/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
Other adverse events
| Measure |
PCI-32765
n=135 participants at risk
Ibrutinib 420 mg daily.
|
Chlorambucil
n=132 participants at risk
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.8%
24/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
20.5%
27/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.8%
20/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
22.0%
29/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
12.9%
17/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.0%
4/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Dry eye
|
17.0%
23/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
4.5%
6/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Lacrimation increased
|
13.3%
18/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
6.1%
8/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Vision blurred
|
13.3%
18/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
7.6%
10/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Visual acuity reduced
|
11.1%
15/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Eye pain
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Vitreous floaters
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
4.5%
6/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Eye disorders
Cataract
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.2%
57/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
16.7%
22/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
30/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
39.4%
52/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
20/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
15.9%
21/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
18/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
20.5%
27/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.6%
17/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
10.6%
14/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
15/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
9/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Fatigue
|
30.4%
41/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
37.9%
50/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Oedema peripheral
|
18.5%
25/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
9.1%
12/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Pyrexia
|
16.3%
22/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
12.9%
17/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
General disorders
Asthenia
|
7.4%
10/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.3%
22/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
17.4%
23/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Urinary tract infection
|
9.6%
13/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
7.6%
10/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Conjunctivitis
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
10/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
4.5%
6/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Cellulitis
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Sinusitis
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Skin infection
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
5.3%
7/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Investigations
Weight decreased
|
10.4%
14/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
12.1%
16/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Investigations
Platelet count decreased
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
4.5%
6/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.6%
13/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
14.4%
19/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
22/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
6.8%
9/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.9%
16/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
6.8%
9/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
15/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
5.3%
7/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
13/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
5.3%
7/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.0%
4/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Headache
|
11.9%
16/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
9.8%
13/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Nervous system disorders
Dizziness
|
11.1%
15/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
12.1%
16/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Psychiatric disorders
Insomnia
|
8.1%
11/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
6.8%
9/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Psychiatric disorders
Anxiety
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
1.5%
2/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
30/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
15.2%
20/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
14/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
9.8%
13/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
9/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.76%
1/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
9.6%
13/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
9/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
7.6%
10/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
5.3%
7/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
8/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
3.8%
5/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
7/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
2.3%
3/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
|
Vascular disorders
Hypertension
|
13.3%
18/135 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
0.00%
0/132 • From first dose of study drug to within 30 days of last dose or starting new anti-cancer therapy, whichever occurs earlier, up to 04May2015 ( data cutoff date for final analysis).
269 subjects were randomized on the study of which 2 subjects withdrew without treatment and were not included in the number of participants at risk. Investigators assess the occurrence of AEs and SAEs at all patient evaluation time points during the study.
|
Additional Information
Dr. Lori Styles, Medical Monitor
Pharmacyclics LLC
Phone: +1 (408) 215-3770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place