Trial Outcomes & Findings for A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer (NCT NCT00333775)
NCT ID: NCT00333775
Last Updated: 2016-01-27
Results Overview
Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
736 participants
Primary outcome timeframe
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Results posted on
2016-01-27
Participant Flow
21 participants randomized to the placebo group received bevacizumab 7.5 mg/kg (n=5) or 15.0 mg/kg (n=16). Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
Participant milestones
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Overall Study
STARTED
|
241
|
248
|
247
|
|
Overall Study
Received Treatment
|
238
|
247
|
245
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
241
|
248
|
247
|
Reasons for withdrawal
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Overall Study
Death
|
144
|
149
|
143
|
|
Overall Study
In Follow-up When Study Stopped
|
87
|
92
|
96
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
8
|
Baseline Characteristics
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=241 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=248 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=247 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Total
n=736 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 10.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
736 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)Population: Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.
Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).
Outcome measures
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=241 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=248 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=247 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Progression-free Survival
|
8.0 Months
Interval 7.2 to 8.3
|
8.7 Months
Interval 8.2 to 9.9
|
8.8 Months
Interval 8.4 to 10.2
|
SECONDARY outcome
Timeframe: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)Population: Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.
Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=207 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=201 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=206 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Percentage of Participants With a Complete Response or a Partial Response
Complete response
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
|
Percentage of Participants With a Complete Response or a Partial Response
Partial response
|
43.5 Percentage of participants
Interval 36.6 to 50.5
|
52.2 Percentage of participants
Interval 45.1 to 59.3
|
62.1 Percentage of participants
Interval 55.1 to 68.8
|
SECONDARY outcome
Timeframe: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)Population: Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.
Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.
Outcome measures
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=92 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=111 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=130 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Duration of Response
|
6.4 Months
Interval 5.8 to 6.9
|
7.2 Months
Interval 6.4 to 9.1
|
7.0 Months
Interval 6.4 to 8.5
|
SECONDARY outcome
Timeframe: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)Population: Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.
Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.
Outcome measures
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=241 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=248 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=247 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Time to Treatment Failure
|
6.1 months
Interval 5.6 to 7.0
|
7.0 months
Interval 6.1 to 7.7
|
7.7 months
Interval 7.1 to 8.0
|
SECONDARY outcome
Timeframe: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)Population: Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.
Overall survival was defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=241 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=248 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=247 Participants
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Overall Survival
|
NA Months
Due to the low number of events, the median and lower and upper limits of the 95% confidence interval could not be reliably estimated.
|
NA Months
Interval 15.7 to
Due to the low number of events, the median and upper limit of the 95% confidence interval could not be reliably estimated.
|
NA Months
Interval 14.9 to
Due to the low number of events, the median and upper limit of the 95% confidence interval could not be reliably estimated.
|
Adverse Events
Docetaxel 100 mg/m^2 Plus Placebo
Serious events: 82 serious events
Other events: 216 other events
Deaths: 0 deaths
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
Serious events: 106 serious events
Other events: 251 other events
Deaths: 0 deaths
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
Serious events: 120 serious events
Other events: 260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=217 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=252 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=261 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Eye disorders
Cataract
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Surgical and medical procedures
Vertebroplasty
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Microangiopathy
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Embolism venous
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Flushing
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Phlebitis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Venous thrombosis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Arrhythmia
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.7%
21/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
11.5%
29/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
14.2%
37/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
4/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.2%
13/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.9%
18/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Infection
|
2.3%
5/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Neutropenic sepsis
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Pneumonia
|
1.8%
4/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Neutropenic infection
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Central line infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Clostridial infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Paronychia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Postoperative wound infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Respiratory tract infection
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Anal infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Appendicitis perforated
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Bacterial sepsis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Endophthalmitis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Lung infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Nail bed infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Oral candidiasis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Periodontal infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Peritonsillar abscess
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Sinusitis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Stent related infection
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Wound infection
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.4%
6/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
3.1%
8/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
4/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.5%
4/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.1%
3/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Colitis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Pyrexia
|
1.4%
3/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.4%
6/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.7%
7/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Asthenia
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.4%
6/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.5%
4/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Mucosal inflammation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Oedema peripheral
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Fatigue
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
General physical health deterioration
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Pain
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Catheter related complication
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Chest pain
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Death
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Face oedema
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Impaired healing
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Inflammation
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Multi-organ failure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Oedema
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
2/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.1%
3/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.1%
3/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
3/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.77%
2/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
3/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.1%
3/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
1.2%
3/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.46%
1/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.38%
1/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.40%
1/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.00%
0/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
Other adverse events
| Measure |
Docetaxel 100 mg/m^2 Plus Placebo
n=217 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg
n=252 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg
n=261 participants at risk
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|---|---|
|
General disorders
Fatigue
|
44.2%
96/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
41.7%
105/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
41.8%
109/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Asthenia
|
38.2%
83/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
34.9%
88/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
37.2%
97/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Mucosal inflammation
|
22.1%
48/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
34.5%
87/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
29.9%
78/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Oedema peripheral
|
41.0%
89/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
25.0%
63/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
23.4%
61/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Pyrexia
|
20.7%
45/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
24.2%
61/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
24.1%
63/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Oedema
|
14.7%
32/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.8%
12/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.0%
21/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Pain
|
9.2%
20/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.3%
16/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.1%
16/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Chest pain
|
8.8%
19/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.0%
10/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.7%
20/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
General disorders
Malaise
|
2.8%
6/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.0%
10/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.7%
15/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.0%
154/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
71.8%
181/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
70.1%
183/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
40.1%
87/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
46.8%
118/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
45.2%
118/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
21.7%
47/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
31.7%
80/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
26.8%
70/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.8%
43/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
17.1%
43/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
18.0%
47/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.7%
32/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.1%
33/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
9.6%
25/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.2%
20/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.3%
26/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
12.6%
33/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
19/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
11.1%
28/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.8%
23/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
4.1%
9/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.3%
21/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
9.6%
25/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.1%
11/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.3%
21/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.7%
20/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
6.9%
15/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.3%
16/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.6%
12/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.6%
14/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
3.8%
10/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
48.8%
106/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
56.7%
143/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
53.6%
140/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
53.9%
117/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
45.6%
115/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
50.6%
132/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Stomatitis
|
27.6%
60/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
50.4%
127/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
44.1%
115/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
29.5%
64/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
35.3%
89/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
29.5%
77/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
27.2%
59/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
25.4%
64/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
28.7%
75/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.0%
39/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
17.9%
45/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
22.2%
58/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.4%
27/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
14.3%
36/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
16.5%
43/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.7%
34/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
9.5%
24/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
12.3%
32/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.5%
14/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.7%
22/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.4%
22/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Toothache
|
6.0%
13/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.2%
13/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.4%
14/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Dysphagia
|
5.5%
12/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.2%
13/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.0%
13/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.0%
15/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.6%
12/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Gastrointestinal disorders
Gingivitis
|
1.8%
4/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.4%
11/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.1%
16/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Headache
|
25.8%
56/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
34.1%
86/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
30.3%
79/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Dysgeusia
|
27.2%
59/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
30.6%
77/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
24.1%
63/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
27.6%
60/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
26.6%
67/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
24.1%
63/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Paraesthesia
|
18.4%
40/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
18.3%
46/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
19.5%
51/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Neuropathy peripheral
|
13.8%
30/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.9%
35/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.0%
26/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Dizziness
|
11.5%
25/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.3%
26/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
11.9%
31/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Nervous system disorders
Hypoaesthesia
|
5.1%
11/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
0.79%
2/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.3%
6/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.9%
80/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
32.5%
82/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
33.7%
88/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.1%
48/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
29.4%
74/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
34.5%
90/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.1%
37/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
22.2%
56/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
16.9%
44/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.7%
45/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
14.3%
36/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
16.9%
44/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.5%
38/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.9%
35/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
16.1%
42/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.6%
23/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.5%
34/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.8%
36/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.6%
14/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.5%
17/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.0%
13/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.8%
12/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.6%
12/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.1%
9/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.3%
16/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
3.4%
9/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.7%
47/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
48.8%
123/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
49.0%
128/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
42/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
26.6%
67/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
23.4%
61/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.6%
49/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
17.5%
44/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
23.0%
60/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.8%
19/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.3%
26/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
14.6%
38/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.8%
19/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.7%
27/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.7%
28/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.6%
10/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
9.5%
24/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.7%
28/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
13/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.0%
10/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.5%
17/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.4%
3/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.2%
13/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.6%
12/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Eye disorders
Lacrimation increased
|
29.0%
63/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
45.2%
114/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
46.0%
120/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Eye disorders
Conjunctivitis
|
5.1%
11/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.3%
16/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
14.9%
39/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
23/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.7%
22/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.7%
28/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
14/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.9%
20/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.4%
35/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
18/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.7%
27/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.7%
20/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Influenza
|
5.5%
12/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
10.3%
26/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.7%
15/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Rhinitis
|
4.1%
9/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.4%
11/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.9%
18/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Infections and infestations
Sinusitis
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.0%
10/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.3%
19/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.3%
44/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
20.2%
51/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
20.3%
53/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.1%
37/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.5%
34/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
12.3%
32/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.5%
14/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
8.3%
21/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.7%
20/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Hypertension
|
14.7%
32/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
17.5%
44/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
25.3%
66/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Hot flush
|
7.4%
16/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.3%
16/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.3%
19/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Flushing
|
5.5%
12/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.0%
15/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.3%
19/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Vascular disorders
Lymphoedema
|
6.9%
15/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
7.5%
19/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
3.1%
8/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
58/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
31.0%
78/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
32.6%
85/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
15.7%
34/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
12.3%
31/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
13.4%
35/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Psychiatric disorders
Depression
|
5.1%
11/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.2%
13/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.0%
13/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.4%
11/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
6.1%
16/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Investigations
Weight decreased
|
5.5%
12/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
11.5%
29/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
11.5%
30/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Investigations
Weight increased
|
7.4%
16/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.0%
5/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
2.7%
7/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
8/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.8%
12/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
9.2%
24/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
|
Ear and labyrinth disorders
Vertigo
|
4.6%
10/217
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
4.4%
11/252
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
5.7%
15/261
Safety population: All randomized participants exposed to study medication. Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER