Trial Outcomes & Findings for A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (NCT NCT01094184)
NCT ID: NCT01094184
Last Updated: 2018-03-22
Results Overview
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
COMPLETED
PHASE4
49 participants
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
2018-03-22
Participant Flow
A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment
Participant milestones
| Measure |
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
13
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
35
|
11
|
Reasons for withdrawal
| Measure |
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Death
|
35
|
11
|
Baseline Characteristics
A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab 10 mg/kg Q2W
n=36 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.22 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
49 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: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)Population: Intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of all study medication (taxane and bevacizumab). 'Overall Number of Participants Analyzed'=participants who completed the questionnaire at Baseline; 'Number Analyzed'=participants who completed the questionnaire at Baseline and at specified time point.
FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=12 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=31 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Baseline
|
102.21 units on a scale
Standard Deviation 21.036
|
98.3 units on a scale
Standard Deviation 21.342
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Change at Cycle 2
|
-2.48 units on a scale
Standard Deviation 14.697
|
5.83 units on a scale
Standard Deviation 17.027
|
PRIMARY outcome
Timeframe: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=3 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 3
|
14.56 units on a scale
Standard Deviation 13.961
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=6 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=20 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 4
|
0.09 units on a scale
Standard Deviation 12.275
|
1.29 units on a scale
Standard Deviation 16.304
|
PRIMARY outcome
Timeframe: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=2 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 5
|
4.50 units on a scale
Standard Deviation 27.577
|
-10.77 units on a scale
Standard Deviation 11.677
|
PRIMARY outcome
Timeframe: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=7 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=6 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 6
|
10.08 units on a scale
Standard Deviation 21.868
|
9.47 units on a scale
Standard Deviation 16.356
|
PRIMARY outcome
Timeframe: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=7 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 7
|
1.83 units on a scale
|
-6.24 units on a scale
Standard Deviation 13.220
|
PRIMARY outcome
Timeframe: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=4 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 8
|
15.44 units on a scale
Standard Deviation 19.979
|
15.01 units on a scale
Standard Deviation 9.805
|
PRIMARY outcome
Timeframe: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score At Cycle 9
|
7.00 units on a scale
|
-2.43 units on a scale
Standard Deviation 7.762
|
PRIMARY outcome
Timeframe: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=5 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 10
|
4.61 units on a scale
Standard Deviation 13.968
|
2.71 units on a scale
Standard Deviation 20.075
|
PRIMARY outcome
Timeframe: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 11
|
8.17 units on a scale
|
6.67 units on a scale
Standard Deviation 11.889
|
PRIMARY outcome
Timeframe: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 12
|
21.89 units on a scale
|
9.22 units on a scale
Standard Deviation 8.720
|
PRIMARY outcome
Timeframe: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 13
|
—
|
-8.00 units on a scale
Standard Deviation 9.899
|
PRIMARY outcome
Timeframe: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 14
|
2.33 units on a scale
|
6.83 units on a scale
Standard Deviation 5.897
|
PRIMARY outcome
Timeframe: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 15
|
—
|
-6.67 units on a scale
Standard Deviation 8.250
|
PRIMARY outcome
Timeframe: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 16
|
—
|
11.83 units on a scale
Standard Deviation 12.790
|
PRIMARY outcome
Timeframe: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 17
|
—
|
22.63 units on a scale
Standard Deviation 13.157
|
PRIMARY outcome
Timeframe: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 18
|
5.33 units on a scale
|
10.28 units on a scale
Standard Deviation 19.878
|
PRIMARY outcome
Timeframe: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 20
|
—
|
20.06 units on a scale
Standard Deviation 12.787
|
PRIMARY outcome
Timeframe: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 21
|
10.33 units on a scale
|
25.75 units on a scale
Standard Deviation 5.303
|
PRIMARY outcome
Timeframe: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 22
|
—
|
13.67 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 23
|
7.33 units on a scale
|
9.67 units on a scale
Standard Deviation 20.742
|
PRIMARY outcome
Timeframe: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 24
|
—
|
6.00 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 25
|
11.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 26
|
—
|
3.22 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 27
|
12.33 units on a scale
|
-26.78 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 28
|
16.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 29
|
9.78 units on a scale
|
-3.00 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 30
|
—
|
-3.11 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 32
|
10.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 36
|
3.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 37
|
5.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 39
|
9.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 42
|
10.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 44
|
11.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at Cycle 46
|
13.33 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=7 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=14 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in FACT-B Score at End of Study
|
-1.01 units on a scale
Standard Deviation 9.343
|
-10.33 units on a scale
Standard Deviation 13.509
|
PRIMARY outcome
Timeframe: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=10 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=31 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Baseline
|
0.8152 units on a scale
Standard Deviation 0.12211
|
0.6391 units on a scale
Standard Deviation 0.25595
|
|
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Change at Cycle 2
|
-0.2074 units on a scale
Standard Deviation 0.19784
|
0.1090 units on a scale
Standard Deviation 0.23563
|
PRIMARY outcome
Timeframe: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
|
0.1920 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=5 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=20 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
|
-0.0906 units on a scale
Standard Deviation 0.06661
|
-0.0105 units on a scale
Standard Deviation 0.28263
|
PRIMARY outcome
Timeframe: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
|
0.2280 units on a scale
|
-0.1164 units on a scale
Standard Deviation 0.10045
|
PRIMARY outcome
Timeframe: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=6 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
|
-0.0735 units on a scale
Standard Deviation 0.24131
|
0.0474 units on a scale
Standard Deviation 0.23827
|
PRIMARY outcome
Timeframe: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=7 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
|
—
|
-0.0331 units on a scale
Standard Deviation 0.18865
|
PRIMARY outcome
Timeframe: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=3 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=6 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
|
-0.0523 units on a scale
Standard Deviation 0.05250
|
0.0627 units on a scale
Standard Deviation 0.23917
|
PRIMARY outcome
Timeframe: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
|
—
|
-0.1904 units on a scale
Standard Deviation 0.24194
|
PRIMARY outcome
Timeframe: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=3 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
|
-0.0540 units on a scale
Standard Deviation 0.24990
|
0.0253 units on a scale
Standard Deviation 0.32169
|
PRIMARY outcome
Timeframe: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
|
—
|
0.0018 units on a scale
Standard Deviation 0.20907
|
PRIMARY outcome
Timeframe: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
|
-0.0520 units on a scale
|
0.0997 units on a scale
Standard Deviation 0.35679
|
PRIMARY outcome
Timeframe: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
|
—
|
-0.0930 units on a scale
Standard Deviation 0.13152
|
PRIMARY outcome
Timeframe: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
|
-0.3320 units on a scale
|
0.0620 units on a scale
Standard Deviation 0.11033
|
PRIMARY outcome
Timeframe: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
|
—
|
0.0175 units on a scale
Standard Deviation 0.19021
|
PRIMARY outcome
Timeframe: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
|
—
|
0.0060 units on a scale
Standard Deviation 0.21806
|
PRIMARY outcome
Timeframe: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
|
—
|
0.1057 units on a scale
Standard Deviation 0.17756
|
PRIMARY outcome
Timeframe: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
|
-0.1570 units on a scale
|
0.0970 units on a scale
Standard Deviation 0.01414
|
PRIMARY outcome
Timeframe: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
|
—
|
0.1035 units on a scale
Standard Deviation 0.19670
|
PRIMARY outcome
Timeframe: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
|
-0.1570 units on a scale
|
0.2955 units on a scale
Standard Deviation 0.26658
|
PRIMARY outcome
Timeframe: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
|
—
|
0.0710 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
|
-0.2280 units on a scale
|
0.0625 units on a scale
Standard Deviation 0.06293
|
PRIMARY outcome
Timeframe: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
|
—
|
0.0540 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
|
-0.3320 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
|
—
|
0.0180 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
|
-0.3320 units on a scale
|
0.0540 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
|
-0.2610 units on a scale
|
-0.0860 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
|
—
|
0.0540 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
|
-0.2610 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
|
-0.3320 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
|
-0.3320 units on a scale
|
—
|
PRIMARY outcome
Timeframe: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=5 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=14 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
|
-0.1178 units on a scale
Standard Deviation 0.14225
|
-0.1344 units on a scale
Standard Deviation 0.20511
|
PRIMARY outcome
Timeframe: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=12 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=30 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
Baseline
|
60.3 mm
Standard Deviation 26.96
|
64.8 mm
Standard Deviation 24.34
|
|
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
Change at Cycle 2
|
-8.3 mm
Standard Deviation 19.41
|
-1.0 mm
Standard Deviation 18.59
|
PRIMARY outcome
Timeframe: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=3 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 3
|
20.0 mm
Standard Deviation 26.46
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=6 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=19 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 4
|
3.3 mm
Standard Deviation 29.27
|
-1.9 mm
Standard Deviation 18.23
|
PRIMARY outcome
Timeframe: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=2 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 5
|
7.0 mm
Standard Deviation 46.67
|
-8.2 mm
Standard Deviation 17.57
|
PRIMARY outcome
Timeframe: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=7 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=6 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 6
|
21.4 mm
Standard Deviation 35.69
|
9.8 mm
Standard Deviation 22.00
|
PRIMARY outcome
Timeframe: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 7
|
-9.0 mm
|
-3.6 mm
Standard Deviation 12.10
|
PRIMARY outcome
Timeframe: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=3 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 8
|
35.0 mm
Standard Deviation 22.91
|
11.0 mm
Standard Deviation 27.60
|
PRIMARY outcome
Timeframe: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=2 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 9
|
27.5 mm
Standard Deviation 45.96
|
-5.8 mm
Standard Deviation 15.43
|
PRIMARY outcome
Timeframe: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=5 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 10
|
14.0 mm
Standard Deviation 32.79
|
6.0 mm
Standard Deviation 21.91
|
PRIMARY outcome
Timeframe: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=5 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 11
|
40.0 mm
|
2.0 mm
Standard Deviation 24.14
|
PRIMARY outcome
Timeframe: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 12
|
60.0 mm
|
13.7 mm
Standard Deviation 24.19
|
PRIMARY outcome
Timeframe: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 13
|
—
|
-3.0 mm
Standard Deviation 2.83
|
PRIMARY outcome
Timeframe: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 14
|
9.0 mm
|
-5.0 mm
Standard Deviation 20.00
|
PRIMARY outcome
Timeframe: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 15
|
—
|
5.0 mm
Standard Deviation 7.07
|
PRIMARY outcome
Timeframe: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 16
|
—
|
7.3 mm
Standard Deviation 37.87
|
PRIMARY outcome
Timeframe: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=3 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 17
|
—
|
30.0 mm
Standard Deviation 25.00
|
PRIMARY outcome
Timeframe: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 18
|
10.0 mm
|
9.5 mm
Standard Deviation 55.86
|
PRIMARY outcome
Timeframe: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=4 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 20
|
—
|
15.0 mm
Standard Deviation 31.36
|
PRIMARY outcome
Timeframe: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 21
|
8.0 mm
|
27.5 mm
Standard Deviation 31.82
|
PRIMARY outcome
Timeframe: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 22
|
—
|
52.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=2 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 23
|
10.0 mm
|
23.5 mm
Standard Deviation 47.38
|
PRIMARY outcome
Timeframe: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 24
|
—
|
-20.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 25
|
9.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 26
|
—
|
-20.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 27
|
10.0 mm
|
-20.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 28
|
9.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 29
|
10.0 mm
|
-20.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=1 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 30
|
—
|
-20.0 mm
|
PRIMARY outcome
Timeframe: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 32
|
9.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 36
|
8.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 37
|
8.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 39
|
8.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 40
|
5.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 42
|
7.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 44
|
13.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=1 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 46
|
14.0 mm
|
—
|
PRIMARY outcome
Timeframe: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=7 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=12 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at End of Study
|
-1.4 mm
Standard Deviation 22.34
|
-2.7 mm
Standard Deviation 13.17
|
SECONDARY outcome
Timeframe: Baseline up to death (overall approximately 5 years and 9 months)Population: ITT analysis population
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=35 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
|
84.6 percentage of participants
|
97.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to death (overall approximately 5 years and 9 months)Population: ITT analysis population
Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=35 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Survival
|
18.9 months
Interval 12.8 to 33.6
|
11.6 months
Interval 8.5 to 16.9
|
SECONDARY outcome
Timeframe: Baseline up to disease progression (overall approximately 5 years and 9 months)Population: ITT analysis population
Disease progression was defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=35 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Disease Progression
|
69.2 percentage of participants
|
74.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to disease progression (overall approximately 5 years and 9 months)Population: ITT analysis population
Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=35 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Time to Disease Progression
|
7.9 months
Interval 3.2 to 9.7
|
6.7 months
Interval 4.5 to 14.1
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)Population: ITT analysis population. Here, 'Number Analyzed' signifies the number of participants who underwent Karnofsky Performance Status Scale Score assessment at specified time points for different arms, respectively. Data is not reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg Q3W
n=13 Participants
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 10 mg/kg Q2W
n=35 Participants
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 28, 90%
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 28, 100%
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 29, 90%
|
—
|
100.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 30, 80%
|
—
|
100.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 31, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 32, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 33, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 34, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 36, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 37, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 38, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 46, 100%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 47, 100%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 39, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 40, 90%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 42, 100%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 43, 100%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 50%
|
0.0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 60%
|
13.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 70%
|
25.0 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 80%
|
25.0 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 90%
|
38.0 percentage of participants
|
42.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
End of Study, 100%
|
0.0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Baseline, 60%
|
8.0 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Baseline, 70%
|
8.0 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Baseline, 80%
|
25.0 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Baseline, 90%
|
25.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Baseline, 100%
|
33.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 1, 60%
|
0.0 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 1, 70%
|
25.0 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 1, 80%
|
25.0 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 1, 90%
|
25.0 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 1, 100%
|
25.0 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 2, 60%
|
10.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 2, 70%
|
30.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 2, 80%
|
20.0 percentage of participants
|
23.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 2, 90%
|
30.0 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 2, 100%
|
10.0 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 3, 70%
|
30.0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 3, 80%
|
30.0 percentage of participants
|
43.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 3, 90%
|
30.0 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 3, 100%
|
10.0 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 4, 60%
|
13.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 4, 70%
|
13.0 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 4, 80%
|
38.0 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 4, 90%
|
25.0 percentage of participants
|
42.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 4, 100%
|
13.0 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 5, 60%
|
11.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 5, 70%
|
11.0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 5, 80%
|
33.0 percentage of participants
|
37.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 5, 90%
|
33.0 percentage of participants
|
42.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 5, 100%
|
11.0 percentage of participants
|
16.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 6, 80%
|
50.0 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 6, 90%
|
38.0 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 6, 100%
|
13.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 8, 90%
|
43.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 7, 80%
|
43.0 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 7, 90%
|
29.0 percentage of participants
|
64.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 7, 100%
|
29.0 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 8, 70%
|
14.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 8, 80%
|
29.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 8, 100%
|
14.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 9, 60%
|
17.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 9, 70%
|
0.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 9, 80%
|
17.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 9, 90%
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 9, 100%
|
17.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 10, 70%
|
20.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 10, 80%
|
40.0 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 10, 90%
|
20.0 percentage of participants
|
73.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 10, 100%
|
20.0 percentage of participants
|
18.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 11, 70%
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 11, 80%
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 11, 90%
|
25.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 11, 100%
|
25.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 12, 70%
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 12, 80%
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 12, 90%
|
25.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 12, 100%
|
25.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 13, 90%
|
100.0 percentage of participants
|
88.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 13, 100%
|
0.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 14, 80%
|
0.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 14, 90%
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 14, 100%
|
0.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 15, 80%
|
0.0 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 45, 100%
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 15, 90%
|
100.0 percentage of participants
|
71.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 15, 100%
|
0.0 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 16, 80%
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 16, 90%
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 16, 100%
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 17, 90%
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 17, 100%
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 18, 90%
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 18, 100%
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 19, 90%
|
0.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 19, 100%
|
100.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 20, 80%
|
100.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 20, 90%
|
0.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 20, 100%
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 21, 90%
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 21, 100%
|
0.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 22, 90%
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 22, 100%
|
0.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 23, 90%
|
100.0 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 23, 100%
|
0.0 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 24, 90%
|
100.0 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 24, 100%
|
0.0 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 25, 90%
|
100.0 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 25, 100%
|
0.0 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 26, 90%
|
100.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 26, 100%
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 27, 90%
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Cycle 27, 100%
|
0.0 percentage of participants
|
50.0 percentage of participants
|
Adverse Events
Bevacizumab 10 mg/kg Q2W
Bevacizumab 15 mg/kg Q3W
Serious adverse events
| Measure |
Bevacizumab 10 mg/kg Q2W
n=36 participants at risk
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 15 mg/kg Q3W
n=13 participants at risk
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Disease progression
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Fatigue
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Pain
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Immune system disorders
Hypersensitivity
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Device related infection
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Infection
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Localised infection
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Tonsillitis
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Injury, poisoning and procedural complications
Overdose
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Facial paralysis
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Suicidal ideation
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Deep vein thrombosis
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
Other adverse events
| Measure |
Bevacizumab 10 mg/kg Q2W
n=36 participants at risk
Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab 15 mg/kg Q3W
n=13 participants at risk
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Dry eye
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Eye irritation
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Eye pain
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Eyelid ptosis
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Hyphaema
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Eye disorders
Vision blurred
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Constipation
|
38.9%
14/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
38.5%
5/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.6%
11/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
38.5%
5/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
36.1%
13/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
30.8%
4/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
4/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Chills
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Fatigue
|
72.2%
26/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
69.2%
9/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Mucosal inflammation
|
30.6%
11/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Oedema peripheral
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Pain
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Pyrexia
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
General disorders
Ulcer
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Cellulitis
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Device related infection
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Nail infection
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Nasopharyngitis
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Oral herpes
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Paronychia
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
22.2%
8/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Blood bilirubin increased
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Neutrophil count decreased
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Weight decreased
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
Weight increased
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
White blood cell count decreased
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Investigations
White blood cells urine positive
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
6/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Dysgeusia
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Headache
|
30.6%
11/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Lethargy
|
13.9%
5/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Neuralgia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Neuropathy peripheral
|
47.2%
17/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
61.5%
8/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Nervous system disorders
Tremor
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Renal and urinary disorders
Haematuria
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Reproductive system and breast disorders
Breast pain
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
10/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
30.8%
4/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
9/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
38.9%
14/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
30.8%
4/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.6%
11/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.4%
7/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
1/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
11.1%
4/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
16.7%
6/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
15.4%
2/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
3/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
23.1%
3/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
6/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
30.8%
4/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Flushing
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Hot flush
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Hypertension
|
25.0%
9/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
30.8%
4/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Hypotension
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Orthostatic hypotension
|
5.6%
2/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
0.00%
0/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/36 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
7.7%
1/13 • Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
|
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