Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer (NCT NCT00811135)
NCT ID: NCT00811135
Last Updated: 2016-09-29
Results Overview
Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Results posted on
2016-09-29
Participant Flow
Screening details were taken 28 days prior to baseline. There were 88 participants included from 23 centers.
Participant milestones
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram \[mg/kg\]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m\^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
88
|
Reasons for withdrawal
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram \[mg/kg\]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m\^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
|
Overall Study
Adverse Event/Intercurrent Illness
|
8
|
|
Overall Study
Death
|
3
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Violation of Selection Criteria
|
1
|
|
Overall Study
Refused Treatment
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Administrative/Other Unspecified
|
11
|
|
Overall Study
Ongoing
|
59
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
|
|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 10.94 • n=93 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
|
75.0 percentage of participants
Interval 64.6 to 83.6
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
|
Number of Participants With Disease Progression or Death
|
70 participants
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
|
Progression Free Survival (PFS)
|
14.2 months
Interval 10.5 to 14.9
|
SECONDARY outcome
Timeframe: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
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Number of Participants With Overall Survival (OS)
|
40 participants
|
SECONDARY outcome
Timeframe: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
|
Overall Survival (OS)
|
31.8 months
Interval 26.3 to 38.2
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
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Number of Participants With Time to Progression (TTP)
|
62 participants
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
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Time to Progression (TTP)
|
14.5 months
Interval 11.0 to 17.0
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
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|---|---|
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Number of Participants With Response
|
66 participants
|
SECONDARY outcome
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)Population: ITT population
DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 Participants
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
|
|---|---|
|
Duration of Response (DR)
|
12.7 months
Interval 10.2 to 17.7
|
Adverse Events
Trastuzumab + Bevacizumab + Capecitabine
Serious events: 20 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 participants at risk
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
|
|---|---|
|
Cardiac disorders
Cardiac Failure
|
2.3%
2/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Cardiac disorders
Intracardiac thrombus
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Enteritis
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Chest pain
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Death
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Infections and infestations
Erysipelas
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Nervous system disorders
Presyncope
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Nervous system disorders
Sensory disturbance
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
2/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Vascular disorders
Embolism
|
1.1%
1/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
Other adverse events
| Measure |
Trastuzumab + Bevacizumab + Capecitabine
n=88 participants at risk
Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m\^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
73.9%
65/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.9%
14/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.0%
37/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
24/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
15/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
11.4%
10/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.2%
9/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
10.2%
9/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
9/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
5/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.7%
5/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Asthenia
|
36.4%
32/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Pyrexia
|
20.5%
18/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Fatigue
|
12.5%
11/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Mucosal inflammation
|
11.4%
10/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Oedema peripheral
|
6.8%
6/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
General disorders
Chest pain
|
6.8%
6/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
39.8%
35/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
11/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
7/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
10/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
9/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
8/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
8/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
6/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Vascular disorders
Hypertension
|
38.6%
34/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Nervous system disorders
Headache
|
15.9%
14/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
5/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.6%
12/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
7/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
5.7%
5/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
|
|
Investigations
Weight decreased
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6.8%
6/88 • Up to 28 days after the last study treatment dose (maximum treatment time = approximately 44 months)
The safety population comprised of all participants who received at least one dose of any study medication.
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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 that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER