Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer. (NCT NCT00391092)
NCT ID: NCT00391092
Last Updated: 2015-08-28
Results Overview
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
424 participants
Primary outcome timeframe
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Results posted on
2015-08-28
Participant Flow
The participants were randomized 1:1 using a block design randomization procedure with stratification (for prior adjuvant/neo-adjuvant taxane, trastuzumab as part of adjuvant treatment versus no trastuzumab, estrogen/progesterone receptor hormone receptor status and measurable disease) to avoid an imbalance of important prognostic factors.
Participant milestones
| Measure |
Trastuzumab + Docetaxel
Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m\^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Overall Study
STARTED
|
208
|
216
|
|
Overall Study
Received Treatment
|
206
|
215
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
208
|
216
|
Reasons for withdrawal
| Measure |
Trastuzumab + Docetaxel
Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m\^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Overall Study
Death
|
78
|
81
|
|
Overall Study
Lost to Follow-up
|
13
|
18
|
|
Overall Study
Alive on treatment
|
29
|
33
|
|
Overall Study
Alive in follow-up
|
88
|
84
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Baseline characteristics by cohort
| Measure |
Trastuzumab + Docetaxel
n=208 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=216 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
208 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)Population: ITT Population
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=208 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=216 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
13.7 months
Interval 11.4 to 16.3
|
16.5 months
Interval 14.1 to 19.1
|
SECONDARY outcome
Timeframe: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)Population: ITT Population
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=208 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=216 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Overall Survival (OS)
|
38.3 months
Interval 34.3 to
The upper range of 95% confidence interval (CI) was not calculable due to immature OS data as greater than 50% of participants were censored at the time of clinical cutoff (30 June 2011).
|
38.5 months
Interval 32.1 to
The upper range of 95% confidence interval (CI) was not calculable due to immature OS data as greater than 50% of participants were censored at the time of clinical cutoff (30 June 2011).
|
SECONDARY outcome
Timeframe: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)Population: ITT Population; only participants with measurable disease at baseline were included in the analysis.
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=176 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=183 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
|
69.9 percentage of participants
Interval 62.5 to 76.6
|
74.3 percentage of participants
Interval 67.4 to 80.5
|
SECONDARY outcome
Timeframe: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)Population: ITT Population: only participants with a best OR of CR or PR were included in the analysis.
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=123 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=136 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Duration of Response (DR)
|
11.4 months
Interval 9.1 to 13.2
|
14.6 months
Interval 12.0 to 17.1
|
SECONDARY outcome
Timeframe: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)Population: ITT Population
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=208 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=216 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
7.7 months
Interval 6.3 to 8.6
|
9.8 months
Interval 7.9 to 10.9
|
SECONDARY outcome
Timeframe: Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])Population: ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=173 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=189 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Physical Well-Being: Baseline (n=173,189)
|
21.20 units on a scale
Standard Deviation 5.74
|
21.47 units on a scale
Standard Deviation 5.07
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Social Well-Being: Baseline (n=173,189)
|
20.59 units on a scale
Standard Deviation 5.75
|
20.88 units on a scale
Standard Deviation 5.77
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Emotional Well-Being: Baseline (n=173,189)
|
14.95 units on a scale
Standard Deviation 4.95
|
15.54 units on a scale
Standard Deviation 4.44
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Functional Well-Being: Baseline (n=173,189)
|
16.34 units on a scale
Standard Deviation 5.83
|
16.36 units on a scale
Standard Deviation 5.57
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-G Score: Baseline (n=173,189)
|
73.30 units on a scale
Standard Deviation 16.60
|
74.49 units on a scale
Standard Deviation 14.50
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Breast Specific: Baseline (n=173,189)
|
21.67 units on a scale
Standard Deviation 6.43
|
22.84 units on a scale
Standard Deviation 5.85
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-B Score: Baseline (n=173,189)
|
94.97 units on a scale
Standard Deviation 20.50
|
97.46 units on a scale
Standard Deviation 17.71
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Trial Outcome Index: Baseline (n=173,189)
|
59.54 units on a scale
Standard Deviation 14.03
|
60.85 units on a scale
Standard Deviation 12.61
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Physical Well-Being: Cycle 3 (n=145,173)
|
20.19 units on a scale
Standard Deviation 4.89
|
19.96 units on a scale
Standard Deviation 5.05
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Social Well-Being: Cycle 3 (n=145,173)
|
20.64 units on a scale
Standard Deviation 5.32
|
21.19 units on a scale
Standard Deviation 5.44
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Emotional Well-Being: Cycle 3 (n=145,173)
|
16.47 units on a scale
Standard Deviation 4.19
|
16.70 units on a scale
Standard Deviation 4.36
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Functional Well-Being: Cycle 3 (n=145, 173)
|
15.43 units on a scale
Standard Deviation 5.33
|
16.20 units on a scale
Standard Deviation 5.22
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-G Score: Cycle 3 (n=145,173)
|
72.94 units on a scale
Standard Deviation 14.81
|
74.05 units on a scale
Standard Deviation 14.35
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Breast Specific: Cycle 3 (n=145,173)
|
22.29 units on a scale
Standard Deviation 5.78
|
23.17 units on a scale
Standard Deviation 5.34
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-B Score: Cycle 3 (n=145,173)
|
95.26 units on a scale
Standard Deviation 18.52
|
97.23 units on a scale
Standard Deviation 17.81
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Trial Outcome Index: Cycle 3 (n=145,173)
|
58.04 units on a scale
Standard Deviation 12.80
|
59.33 units on a scale
Standard Deviation 12.49
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Physical Well-Being: Cycle 5 (n=139, 166)
|
19.51 units on a scale
Standard Deviation 4.83
|
19.67 units on a scale
Standard Deviation 4.56
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Social Well-Being: Cycle 5 (n=139, 166)
|
19.36 units on a scale
Standard Deviation 5.26
|
20.68 units on a scale
Standard Deviation 4.92
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Emotional Well-Being: Cycle 5 (n=139, 166)
|
16.05 units on a scale
Standard Deviation 4.44
|
17.07 units on a scale
Standard Deviation 4.30
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Functional Well-Being: Cycle 5 (n=139, 166)
|
14.81 units on a scale
Standard Deviation 5.45
|
15.78 units on a scale
Standard Deviation 4.77
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-G Score: Cycle 5 (n=139, 166)
|
69.78 units on a scale
Standard Deviation 15.04
|
73.21 units on a scale
Standard Deviation 12.49
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Breast Specific: Cycle 5 (n=139, 166)
|
21.65 units on a scale
Standard Deviation 5.83
|
23.15 units on a scale
Standard Deviation 4.90
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-B Score: Cycle 5 (n=139, 166)
|
91.43 units on a scale
Standard Deviation 18.81
|
96.36 units on a scale
Standard Deviation 15.63
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Trial Outcome Index: Cycle 5 (n=139, 166)
|
55.99 units on a scale
Standard Deviation 13.09
|
58.59 units on a scale
Standard Deviation 11.01
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Physical Well-Being: Cycle 11 (n=100, 133)
|
21.71 units on a scale
Standard Deviation 4.54
|
21.56 units on a scale
Standard Deviation 4.53
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Social Well-Being: Cycle 11 (n=100, 133)
|
19.71 units on a scale
Standard Deviation 5.74
|
20.78 units on a scale
Standard Deviation 4.92
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Emotional Well-Being: Cycle 11 (n=100, 133)
|
15.96 units on a scale
Standard Deviation 4.50
|
17.46 units on a scale
Standard Deviation 3.70
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Functional Well-Being: Cycle 11 (n=100, 133)
|
16.25 units on a scale
Standard Deviation 5.16
|
16.98 units on a scale
Standard Deviation 4.92
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-G Score: Cycle 11 (n=100, 133)
|
73.26 units on a scale
Standard Deviation 15.24
|
76.55 units on a scale
Standard Deviation 13.56
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Breast Specific: Cycle 11 (n=100, 133)
|
21.29 units on a scale
Standard Deviation 5.55
|
23.80 units on a scale
Standard Deviation 4.92
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-B Score: Cycle 11 (n=100, 133)
|
94.57 units on a scale
Standard Deviation 18.58
|
100.43 units on a scale
Standard Deviation 16.97
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Trial Outcome Index: Cycle 11 (n=100, 133)
|
59.19 units on a scale
Standard Deviation 12.00
|
62.34 units on a scale
Standard Deviation 11.79
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Physical Well-Being: Post PD (n=33, 39)
|
19.94 units on a scale
Standard Deviation 4.99
|
20.35 units on a scale
Standard Deviation 5.37
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Social Well-Being: Post PD (n=33, 39)
|
19.02 units on a scale
Standard Deviation 5.61
|
19.68 units on a scale
Standard Deviation 4.77
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Emotional Well-Being: Post PD (n=33, 39)
|
14.76 units on a scale
Standard Deviation 4.83
|
14.77 units on a scale
Standard Deviation 4.64
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Functional Well-Being: Post PD (n=33, 39)
|
14.13 units on a scale
Standard Deviation 5.57
|
15.08 units on a scale
Standard Deviation 5.16
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-G Score: Post PD (n=33, 39)
|
67.84 units on a scale
Standard Deviation 14.21
|
70.04 units on a scale
Standard Deviation 15.08
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Breast Specific: Post PD (n=33, 39)
|
22.90 units on a scale
Standard Deviation 4.48
|
22.87 units on a scale
Standard Deviation 5.14
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Total FACT-B Score: Post PD (n=33, 39)
|
90.74 units on a scale
Standard Deviation 16.59
|
92.92 units on a scale
Standard Deviation 18.47
|
|
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Trial Outcome Index: Post PD (n=33, 39)
|
56.97 units on a scale
Standard Deviation 11.16
|
58.47 units on a scale
Standard Deviation 12.43
|
SECONDARY outcome
Timeframe: Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])Population: ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Outcome measures
| Measure |
Trastuzumab + Docetaxel
n=145 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=173 Participants
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-B Score: Cycle 11 (n=100, 133)
|
-0.41 units on a scale
Standard Deviation 27.67
|
2.97 units on a scale
Standard Deviation 24.53
|
|
Change From Baseline for FACT-G and FACT-B
Physical Well-Being: Cycle 3 (n=145,173)
|
-1.01 units on a scale
Standard Deviation 7.54
|
-1.51 units on a scale
Standard Deviation 7.16
|
|
Change From Baseline for FACT-G and FACT-B
Social Well-Being: Cycle 3 (n=145,173)
|
0.05 units on a scale
Standard Deviation 7.83
|
0.32 units on a scale
Standard Deviation 7.93
|
|
Change From Baseline for FACT-G and FACT-B
Emotional Well-Being: Cycle 3 (n=145,173)
|
1.52 units on a scale
Standard Deviation 6.49
|
1.16 units on a scale
Standard Deviation 6.22
|
|
Change From Baseline for FACT-G and FACT-B
Functional Well-Being: Cycle 3 (n=145, 173)
|
-0.91 units on a scale
Standard Deviation 7.90
|
-0.16 units on a scale
Standard Deviation 7.63
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-G Score: Cycle 3 (n=145,173)
|
-0.36 units on a scale
Standard Deviation 22.25
|
-0.44 units on a scale
Standard Deviation 20.40
|
|
Change From Baseline for FACT-G and FACT-B
Breast Specific: Cycle 3 (n=145,173)
|
0.61 units on a scale
Standard Deviation 8.65
|
0.34 units on a scale
Standard Deviation 7.92
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-B Score: Cycle 3 (n=145,173)
|
0.29 units on a scale
Standard Deviation 27.63
|
-0.24 units on a scale
Standard Deviation 25.12
|
|
Change From Baseline for FACT-G and FACT-B
Trial Outcome Index: Cycle 3 (n=145,173)
|
-1.50 units on a scale
Standard Deviation 18.99
|
-1.52 units on a scale
Standard Deviation 17.75
|
|
Change From Baseline for FACT-G and FACT-B
Physical Well-Being: Cycle 5 (n=139, 166)
|
-1.69 units on a scale
Standard Deviation 7.50
|
-1.80 units on a scale
Standard Deviation 6.82
|
|
Change From Baseline for FACT-G and FACT-B
Social Well-Being: Cycle 5 (n=139, 166)
|
-1.23 units on a scale
Standard Deviation 7.79
|
-0.20 units on a scale
Standard Deviation 7.58
|
|
Change From Baseline for FACT-G and FACT-B
Emotional Well-Being: Cycle 5 (n=139, 166)
|
1.09 units on a scale
Standard Deviation 6.65
|
1.53 units on a scale
Standard Deviation 6.18
|
|
Change From Baseline for FACT-G and FACT-B
Functional Well-Being: Cycle 5 (n=139, 166)
|
-1.53 units on a scale
Standard Deviation 7.98
|
-0.58 units on a scale
Standard Deviation 7.33
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-G Score: Cycle 5 (n=139, 166)
|
-3.53 units on a scale
Standard Deviation 22.40
|
-1.28 units on a scale
Standard Deviation 19.14
|
|
Change From Baseline for FACT-G and FACT-B
Breast Specific: Cycle 5 (n=139, 166)
|
-0.03 units on a scale
Standard Deviation 8.68
|
0.31 units on a scale
Standard Deviation 7.63
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-B Score: Cycle 5 (n=139, 166)
|
-3.55 units on a scale
Standard Deviation 27.82
|
-1.10 units on a scale
Standard Deviation 23.62
|
|
Change From Baseline for FACT-G and FACT-B
Trial Outcome Index: Cycle 5 (n=139, 166)
|
-3.55 units on a scale
Standard Deviation 19.19
|
-2.26 units on a scale
Standard Deviation 16.74
|
|
Change From Baseline for FACT-G and FACT-B
Physical Well-Being: Cycle 11 (n=100, 133)
|
0.51 units on a scale
Standard Deviation 7.32
|
0.09 units on a scale
Standard Deviation 6.80
|
|
Change From Baseline for FACT-G and FACT-B
Social Well-Being: Cycle 11 (n=100, 133)
|
-0.89 units on a scale
Standard Deviation 8.13
|
-0.10 units on a scale
Standard Deviation 7.58
|
|
Change From Baseline for FACT-G and FACT-B
Emotional Well-Being: Cycle 11 (n=100, 133)
|
1.00 units on a scale
Standard Deviation 6.69
|
1.92 units on a scale
Standard Deviation 5.78
|
|
Change From Baseline for FACT-G and FACT-B
Functional Well-Being: Cycle 11 (n=100, 133)
|
-0.09 units on a scale
Standard Deviation 7.79
|
0.62 units on a scale
Standard Deviation 7.43
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-G Score: Cycle 11 (n=100, 133)
|
-0.05 units on a scale
Standard Deviation 22.54
|
2.06 units on a scale
Standard Deviation 19.85
|
|
Change From Baseline for FACT-G and FACT-B
Breast Specific: Cycle 11 (n=100, 133)
|
-0.38 units on a scale
Standard Deviation 8.49
|
0.96 units on a scale
Standard Deviation 7.64
|
|
Change From Baseline for FACT-G and FACT-B
Trial Outcome Index: Cycle 11 (n=100, 133)
|
-0.35 units on a scale
Standard Deviation 18.46
|
1.49 units on a scale
Standard Deviation 17.26
|
|
Change From Baseline for FACT-G and FACT-B
Physical Well-Being: Post PD (n=33, 39)
|
-1.25 units on a scale
Standard Deviation 7.61
|
-1.12 units on a scale
Standard Deviation 7.39
|
|
Change From Baseline for FACT-G and FACT-B
Social Well-Being: Post PD (n=33, 39)
|
-1.58 units on a scale
Standard Deviation 8.03
|
-1.19 units on a scale
Standard Deviation 7.48
|
|
Change From Baseline for FACT-G and FACT-B
Emotional Well-Being: Post PD (n=33, 39)
|
-0.20 units on a scale
Standard Deviation 6.92
|
-0.78 units on a scale
Standard Deviation 6.42
|
|
Change From Baseline for FACT-G and FACT-B
Functional Well-Being: Post PD (n=33, 39)
|
-2.22 units on a scale
Standard Deviation 8.06
|
-1.28 units on a scale
Standard Deviation 7.59
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-G Score: Post PD (n=33, 39)
|
-5.46 units on a scale
Standard Deviation 21.85
|
-4.44 units on a scale
Standard Deviation 20.92
|
|
Change From Baseline for FACT-G and FACT-B
Breast Specific: Post PD (n=33, 39)
|
1.22 units on a scale
Standard Deviation 7.84
|
0.03 units on a scale
Standard Deviation 7.79
|
|
Change From Baseline for FACT-G and FACT-B
Total FACT-B Score: Post PD (n=33, 39)
|
-4.23 units on a scale
Standard Deviation 26.37
|
-4.55 units on a scale
Standard Deviation 25.59
|
|
Change From Baseline for FACT-G and FACT-B
Trial Outcome Index: Post PD (n=33, 39)
|
-2.57 units on a scale
Standard Deviation 17.92
|
-2.38 units on a scale
Standard Deviation 17.70
|
Adverse Events
Trastuzumab + Docetaxel
Serious events: 63 serious events
Other events: 198 other events
Deaths: 0 deaths
Trastuzumab + Bevacizumab + Docetaxel
Serious events: 72 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab + Docetaxel
n=206 participants at risk
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=215 participants at risk
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
14/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.4%
18/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.4%
9/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
2.8%
6/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Neutropenic sepsis
|
1.5%
3/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
2.8%
6/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Neutropenic infection
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
1.9%
4/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Urinary tract infection
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.93%
2/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Pneumonia
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
1.9%
4/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Angina gangrenous
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Cellulitis
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.93%
2/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Erysipelas
|
1.5%
3/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Sepsis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Viral infection
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
4/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
2.8%
6/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
1.4%
3/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Aphthous stomatitus
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Stomatitus
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Mitral vavle incompetence
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.93%
2/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Asthenia
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
General physical health deterioration
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Oedema peripheral
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Performance status decreased
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Pyrexia
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
2/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertension
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.93%
2/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Vena cava thrombosis
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Immune system disorders
Hypersensitivity
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Device related infection
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Abscess soft tissue
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Hepatitis C
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Lymphangitis
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Mastitis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Wound infection
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
1.4%
3/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Arrhythmia
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Malaise
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Cholestasis
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Reproductive system and breast disorders
Breast discharge
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Syncope
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Psychiatric disorders
Bipolar I Disorder
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.47%
1/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Investigations
General physical condition
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
0.00%
0/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
Other adverse events
| Measure |
Trastuzumab + Docetaxel
n=206 participants at risk
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.
|
Trastuzumab + Bevacizumab + Docetaxel
n=215 participants at risk
Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
68.4%
141/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
62.8%
135/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
28.6%
59/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
31.6%
68/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.9%
41/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
17.2%
37/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.1%
25/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
13.0%
28/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.6%
26/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
12.6%
27/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
24/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.8%
19/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
11.7%
24/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.0%
15/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.8%
12/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.4%
16/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
2.4%
5/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.4%
16/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.3%
85/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
49.8%
107/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Nausea
|
36.9%
76/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
38.1%
82/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Stomatitis
|
29.6%
61/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
44.2%
95/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Constipation
|
22.8%
47/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
25.1%
54/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
18.0%
37/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
19.5%
42/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
18/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
15.8%
34/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.7%
24/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.7%
23/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
15/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
12.6%
27/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.9%
8/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.2%
22/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
11/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
3.7%
8/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Toothache
|
3.4%
7/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.6%
12/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.0%
15/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
4.7%
10/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Asthenia
|
36.9%
76/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
34.9%
75/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Fatigue
|
23.3%
48/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
32.1%
69/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Oedema peripheral
|
35.0%
72/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
17.2%
37/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Pyrexia
|
19.9%
41/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
23.7%
51/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Influenza like illness
|
8.7%
18/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.9%
17/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Chills
|
5.3%
11/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.0%
15/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
General disorders
Spinal pain
|
1.9%
4/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.1%
11/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.1%
60/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
27.4%
59/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.9%
41/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
29.3%
63/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.0%
37/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
16.3%
35/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.5%
32/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
18.1%
39/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
26/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
14.9%
32/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
25/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.7%
23/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
10/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.9%
17/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.9%
8/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.4%
18/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
7/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
6.5%
14/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Headache
|
19.4%
40/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
30.7%
66/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.2%
52/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
21.4%
46/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Dysgeusia
|
15.5%
32/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
17.2%
37/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Paraesthesia
|
13.6%
28/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
17.2%
37/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.7%
18/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.2%
22/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Dizziness
|
7.8%
16/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
6.5%
14/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.0%
35/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
50.7%
109/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
43/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
20.0%
43/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.3%
46/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
16.7%
36/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.7%
18/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
12.1%
26/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
13/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
12.1%
26/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.9%
8/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
9.8%
21/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.9%
8/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.1%
11/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Eye disorders
Lacrimation increased
|
28.6%
59/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
34.9%
75/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Eye disorders
Conjuctivitis
|
4.4%
9/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.2%
22/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Eye disorders
Dry eye
|
2.9%
6/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.6%
12/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Urinary tract infection
|
16.0%
33/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
12.6%
27/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
20/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.4%
18/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Cystitis
|
8.3%
17/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.8%
19/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Rhinitis
|
7.8%
16/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.9%
17/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
11/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
9.8%
21/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Infections and infestations
Bronchitis
|
7.3%
15/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
4.2%
9/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertension
|
13.1%
27/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
36.7%
79/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hot flush
|
7.8%
16/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.6%
12/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Lymphoedema
|
8.3%
17/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
3.7%
8/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Vascular disorders
Flushing
|
4.9%
10/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.6%
12/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.8%
51/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
20.5%
44/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
24/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
7.4%
16/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Psychiatric disorders
Insomnia
|
10.2%
21/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
8.8%
19/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Psychiatric disorders
Anxiety
|
7.8%
16/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
5.6%
12/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Psychiatric disorders
Depression
|
7.3%
15/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
6.0%
13/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.1%
25/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
18.1%
39/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Investigations
Weight decreased
|
2.9%
6/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
9.3%
20/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Investigations
Weight increased
|
6.3%
13/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
3.7%
8/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Renal and urinary disorders
Proteinuria
|
0.49%
1/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
10.2%
22/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Renal and urinary disorders
Dysuria
|
3.4%
7/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
6.0%
13/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Left ventricular dysfunction
|
8.3%
17/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
11.2%
24/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Immune system disorders
Hypersensitivity
|
6.8%
14/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
4.7%
10/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
|
Ear and labyrinth disorders
Vertigo
|
6.3%
13/206 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
1.4%
3/215 • From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).
Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.
|
Additional Information
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 the 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