Trial Outcomes & Findings for Study of Ruxolitinib in Colorectal Cancer Patients (NCT NCT02119676)
NCT ID: NCT02119676
Last Updated: 2018-02-13
Results Overview
Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
396 participants
Primary outcome timeframe
Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.
Results posted on
2018-02-13
Participant Flow
In Substudy 1, the first subject was enrolled on 29 OCT 2014, and the last subject was enrolled on 23 JUL 2015. In Substudy 2, the first subject was enrolled on 05 NOV 2014, and the last subject was enrolled on 02 OCT 2015.
Substudy 1; 4 participants were assigned a randomization number but were not given study drug because of clinical deterioration or withdrawal of consent. Substudy 2; 9 participants were assigned a randomization number, but weren't given study drug due to clinical deterioration, withdrawal of consent or not meeting all of the eligibility criteria.
Participant milestones
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
88
|
110
|
111
|
|
Overall Study
Treated Patients
|
85
|
86
|
106
|
106
|
|
Overall Study
COMPLETED
|
4
|
2
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
83
|
86
|
97
|
101
|
Reasons for withdrawal
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
17
|
10
|
10
|
|
Overall Study
Disease progression
|
53
|
55
|
68
|
73
|
|
Overall Study
Patient decision, inc. consent withdrawn
|
4
|
5
|
5
|
6
|
|
Overall Study
Physician Decision
|
4
|
2
|
3
|
2
|
|
Overall Study
Death
|
9
|
3
|
2
|
1
|
|
Overall Study
Noncompliance
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
0
|
1
|
0
|
|
Overall Study
Other, unspecified
|
2
|
1
|
3
|
4
|
|
Overall Study
Did not receive study med
|
2
|
2
|
4
|
5
|
Baseline Characteristics
Study of Ruxolitinib in Colorectal Cancer Patients
Baseline characteristics by cohort
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=87 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=88 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=110 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=111 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
n=5 Participants
|
59.5 years
n=7 Participants
|
59.0 years
n=5 Participants
|
59.2 years
n=4 Participants
|
59.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
304 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.Population: Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.
Outcome measures
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=87 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=88 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=110 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=111 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
4.6 months
Interval 3.5 to 5.4
|
5.3 months
Interval 4.3 to 6.0
|
11.4 months
Interval 9.0 to 13.2
|
10.9 months
Interval 7.2 to
Not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.Population: Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=87 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=88 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=110 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=111 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.2 months
Interval 1.9 to 3.0
|
2.1 months
Interval 1.8 to 2.7
|
3.5 months
Interval 3.0 to 3.8
|
2.0 months
Interval 1.9 to 3.1
|
SECONDARY outcome
Timeframe: Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.Population: Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.
Outcome measures
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=87 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=88 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=110 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=111 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0.0 percentage of responders
Interval 0.0 to 4.2
|
0.0 percentage of responders
Interval 0.0 to 4.1
|
2.7 percentage of responders
Interval 0.6 to 7.8
|
4.5 percentage of responders
Interval 1.5 to 10.2
|
SECONDARY outcome
Timeframe: Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.Population: No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.
Duration of response is defined as the time from response (CR/PR) until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.Population: Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.
Outcome measures
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=87 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=88 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=110 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=111 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Disease Control
|
40.2 percentage of participants
Interval 29.9 to 51.3
|
34.1 percentage of participants
Interval 24.3 to 45.0
|
61.8 percentage of participants
Interval 52.1 to 70.9
|
36.9 percentage of participants
Interval 28.0 to 46.6
|
SECONDARY outcome
Timeframe: Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.Population: Safety Population consists of all enrolled participants that received at least one dose of study drug.
TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.
Outcome measures
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=85 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=86 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=106 Participants
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=106 Participants
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants with any TEAEs
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants with Grade 3/4 TEAEs
|
82.4 percentage of participants
|
81.4 percentage of participants
|
77.4 percentage of participants
|
72.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants with any serious TEAE
|
57.6 percentage of participants
|
48.8 percentage of participants
|
34.9 percentage of participants
|
34.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants with a fatal TEAE
|
15.3 percentage of participants
|
9.3 percentage of participants
|
1.9 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Participants who discontinued drug due to of TEAEs
|
14.1 percentage of participants
|
19.8 percentage of participants
|
11.3 percentage of participants
|
10.4 percentage of participants
|
Adverse Events
Substudy 1: Ruxolitinib + Regorafenib
Serious events: 49 serious events
Other events: 85 other events
Deaths: 0 deaths
Substudy 1: Placebo + Regorafenib
Serious events: 42 serious events
Other events: 86 other events
Deaths: 0 deaths
Substudy 2: Ruxolitinib + Regorafenib
Serious events: 37 serious events
Other events: 106 other events
Deaths: 0 deaths
Substudy 2: Placebo + Regorafenib
Serious events: 37 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=85 participants at risk
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=86 participants at risk
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=106 participants at risk
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=106 participants at risk
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
8.1%
7/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Bloody peritoneal effluent
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
4/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Disease progression
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Multi-organ failure
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Obstruction
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Hepatobiliary disorders
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Biliary sepsis
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Hepatic infection bacterial
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Liver abscess
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrospinal fistula
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Lacunar infarction
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
Other adverse events
| Measure |
Substudy 1: Ruxolitinib + Regorafenib
n=85 participants at risk
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 1: Placebo + Regorafenib
n=86 participants at risk
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Ruxolitinib + Regorafenib
n=106 participants at risk
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
Substudy 2: Placebo + Regorafenib
n=106 participants at risk
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
10/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.0%
12/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.5%
27/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
11.3%
12/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.7%
21/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
27.9%
24/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
22.6%
24/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
24.5%
26/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
31.8%
27/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
24.4%
21/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
22.6%
24/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.8%
22/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.6%
32/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
31.4%
27/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
38.7%
41/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
27.4%
29/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.9%
22/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.6%
22/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
28.3%
30/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.8%
22/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
24.7%
21/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.9%
18/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
17.9%
19/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
19.8%
21/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
16/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
23.3%
20/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
22.6%
24/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.2%
15/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
25.9%
22/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.6%
22/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
17.9%
19/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
21.7%
23/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Chills
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
34.1%
29/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
36.0%
31/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.6%
43/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
44.3%
47/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
9.4%
8/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.5%
9/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pain
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
4/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
18.8%
16/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
17.4%
15/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
18.9%
20/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
15.1%
16/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
12.9%
11/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.3%
8/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
8/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.3%
14/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
11.3%
12/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.3%
13/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
14.1%
12/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.0%
12/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.2%
15/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
15.3%
13/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
17.4%
15/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.3%
13/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
15.1%
16/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.5%
31/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
36.0%
31/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
26.4%
28/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.0%
35/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
11/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
8.1%
7/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
11.3%
12/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.4%
8/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.9%
11/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.3%
13/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
7/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
15/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.8%
11/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
13.2%
14/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
7/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
8.5%
9/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.3%
13/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.4%
10/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.4%
10/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
15.3%
13/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
18.6%
16/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
19.8%
21/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
24.5%
26/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.2%
7/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.4%
11/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
9/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.3%
8/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.4%
10/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.9%
11/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.3%
14/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.8%
22/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.5%
27/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
10/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.3%
14/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.2%
15/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.0%
17/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
4/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.4%
10/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
6/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.0%
6/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
7.5%
8/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
9.4%
10/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
42.4%
36/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
44.2%
38/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
57.5%
61/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
47.2%
50/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
5/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.8%
3/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
8/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.0%
12/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
14.2%
15/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
11.3%
12/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.2%
1/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.8%
5/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.9%
2/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
21.2%
18/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.6%
22/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
41.5%
44/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
39.6%
42/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
1.2%
1/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
4/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.94%
1/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
3.5%
3/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
6.6%
7/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.8%
4/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.7%
4/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
3.5%
3/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
4.7%
5/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
2/85 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
2.3%
2/86 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
8.5%
9/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
5.7%
6/106 • From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
Additional Information
Study Director
Incyte Corporation
Phone: 855 463-3463
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER