Trial Outcomes & Findings for A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03635489)
NCT ID: NCT03635489
Last Updated: 2024-10-03
Results Overview
PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Results posted on
2024-10-03
Participant Flow
This study was conducted at 16 centers in mainland China.
Participants were randomized with a 1:1 allocation ratio to receive Bevacizumab(B) + Paclitaxel (P) + Carboplatin (C) or Placebo + Paclitaxel + Carboplatin.
Participant milestones
| Measure |
Placebo + Paclitaxel + Carboplatin
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
49
|
51
|
Reasons for withdrawal
| Measure |
Placebo + Paclitaxel + Carboplatin
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Overall Study
Death
|
19
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Study Ended by Sponsor
|
28
|
34
|
Baseline Characteristics
A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Placebo + Paclitaxel + Carboplatin
n=49 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=51 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
54.1 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
53.6 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.
PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=49 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=51 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
12.32 months
Interval 9.53 to 15.05
|
22.57 months
Interval 18.6 to
The upper bound of the 95% confidence interval (CI) was not reached.
|
SECONDARY outcome
Timeframe: Randomization up to to death from any cause (up to approximately 54.1 months)Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.
OS was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=49 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=51 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS)
|
48.89 months
Interval 40.31 to
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.
ORR was defined as the proportion of participants with complete response (CR) or partial response (PR) as assessed by investigator according to RECIST v.1.1.
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=28 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=24 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
92.9 percentage of participants
Interval 76.5 to 99.12
|
95.8 percentage of participants
Interval 78.88 to 99.89
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a complete or partial response until disease progression or death from any cause (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had an objective response (CR or PR) by the investigator per RECIST v1.1 were included in the analysis.
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression,as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurred first. DOR was evaluated for participants who had a objective response of CR or PR.
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=26 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=23 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR)
|
8.87 months
Interval 7.56 to 13.14
|
16.10 months
Interval 10.81 to
The upper bound of 95% CI was not reached
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Cycle 4 Day 1
|
37.0 percentage of participants
Interval 23.21 to 52.45
|
31.3 percentage of participants
Interval 18.66 to 46.25
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Cycle 7 Day 1
|
40.9 percentage of participants
Interval 26.34 to 56.75
|
42.1 percentage of participants
Interval 26.31 to 58.18
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Cycle 13 Day 1
|
48.4 percentage of participants
Interval 30.15 to 66.94
|
40.0 percentage of participants
Interval 23.87 to 57.89
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Cycle 22 Day 1
|
37.5 percentage of participants
Interval 15.2 to 64.57
|
48.0 percentage of participants
Interval 27.8 to 68.69
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Treatment Completion / Early Termination Visit
|
37.8 percentage of participants
Interval 23.77 to 53.46
|
45.2 percentage of participants
Interval 29.85 to 61.33
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 3 Months
|
37.0 percentage of participants
Interval 19.4 to 57.63
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 6 Months
|
33.3 percentage of participants
Interval 11.82 to 61.62
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 9 Months
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
46.2 percentage of participants
Interval 19.22 to 74.87
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 12 Months
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 18 Months
|
—
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Cycle 4 Day 1
|
26.1 percentage of participants
Interval 14.27 to 41.13
|
33.3 percentage of participants
Interval 20.4 to 48.41
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Cycle 7 Day 1
|
36.4 percentage of participants
Interval 22.41 to 52.23
|
47.4 percentage of participants
Interval 30.98 to 64.18
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Cycle 13 Day 1
|
29.0 percentage of participants
Interval 14.22 to 48.04
|
31.4 percentage of participants
Interval 16.85 to 49.29
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Cycle 22 Day 1
|
25.0 percentage of participants
Interval 7.27 to 52.38
|
40.0 percentage of participants
Interval 21.13 to 61.33
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Treatment Completion / Early Termination Visit
|
33.3 percentage of participants
Interval 20.0 to 48.95
|
33.3 percentage of participants
Interval 19.57 to 49.55
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 3 Months
|
25.9 percentage of participants
Interval 11.11 to 46.28
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 6 Months
|
46.7 percentage of participants
Interval 21.27 to 73.41
|
19.0 percentage of participants
Interval 5.45 to 41.91
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 9 Months
|
25.0 percentage of participants
Interval 3.19 to 65.09
|
23.1 percentage of participants
Interval 5.04 to 53.81
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 12 Months
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 18 Months
|
—
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Cycle 4 Day 1
|
17.4 percentage of participants
Interval 7.82 to 31.42
|
16.7 percentage of participants
Interval 7.48 to 30.22
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Cycle 7 Day 1
|
18.2 percentage of participants
Interval 8.19 to 32.71
|
18.4 percentage of participants
Interval 7.74 to 34.33
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Cycle 13 Day 1
|
45.2 percentage of participants
Interval 27.32 to 63.97
|
34.3 percentage of participants
Interval 19.13 to 52.21
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Cycle 22 Day 1
|
43.8 percentage of participants
Interval 19.75 to 70.12
|
36.0 percentage of participants
Interval 17.97 to 57.48
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Treatment Completion / Early Termination Visit
|
31.1 percentage of participants
Interval 18.17 to 46.65
|
31.0 percentage of participants
Interval 17.62 to 47.09
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 3 Months
|
44.4 percentage of participants
Interval 25.48 to 64.67
|
27.8 percentage of participants
Interval 14.2 to 45.19
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 6 Months
|
13.3 percentage of participants
Interval 1.66 to 40.46
|
23.8 percentage of participants
Interval 8.22 to 47.17
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 9 Months
|
12.5 percentage of participants
Interval 0.32 to 52.65
|
23.1 percentage of participants
Interval 5.04 to 53.81
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 12 Months
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 18 Months
|
—
|
0 percentage of participants
Interval 0.0 to 70.76
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 18 Months
|
—
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Cycle 4 Day 1
|
34.8 percentage of participants
Interval 21.35 to 50.25
|
31.3 percentage of participants
Interval 18.66 to 46.25
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Cycle 7 Day 1
|
25.0 percentage of participants
Interval 13.19 to 40.34
|
36.8 percentage of participants
Interval 21.81 to 54.01
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Cycle 13 Day 1
|
45.2 percentage of participants
Interval 27.32 to 63.97
|
48.6 percentage of participants
Interval 31.38 to 66.01
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Cycle 22 Day 1
|
50.0 percentage of participants
Interval 24.65 to 75.35
|
40.0 percentage of participants
Interval 21.13 to 61.33
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Treatment Completion / Early Termination Visit
|
40.0 percentage of participants
Interval 25.7 to 55.67
|
42.9 percentage of participants
Interval 27.72 to 59.04
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 3 Months
|
48.1 percentage of participants
Interval 28.67 to 68.05
|
33.3 percentage of participants
Interval 18.56 to 50.97
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 6 Months
|
40.0 percentage of participants
Interval 16.34 to 67.71
|
42.9 percentage of participants
Interval 21.82 to 65.98
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 9 Months
|
37.5 percentage of participants
Interval 8.52 to 75.51
|
30.8 percentage of participants
Interval 9.09 to 61.43
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Survival Follow Up 12 Months
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
57.1 percentage of participants
Interval 18.41 to 90.1
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Cycle 4 Day 1
|
28.3 percentage of participants
Interval 15.99 to 43.46
|
29.2 percentage of participants
Interval 16.95 to 44.06
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Cycle 7 Day 1
|
27.3 percentage of participants
Interval 14.96 to 42.79
|
28.9 percentage of participants
Interval 15.42 to 45.9
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Cycle 13 Day 1
|
38.7 percentage of participants
Interval 21.85 to 57.81
|
28.6 percentage of participants
Interval 14.64 to 46.3
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Cycle 22 Day 1
|
43.8 percentage of participants
Interval 19.75 to 70.12
|
36.0 percentage of participants
Interval 17.97 to 57.48
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Treatment Completion / Early Termination Visit
|
28.9 percentage of participants
Interval 16.37 to 44.31
|
33.3 percentage of participants
Interval 19.57 to 49.55
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 3 Months
|
33.3 percentage of participants
Interval 16.52 to 53.96
|
47.2 percentage of participants
Interval 30.41 to 64.51
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 6 Months
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
28.6 percentage of participants
Interval 11.28 to 52.18
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 9 Months
|
37.5 percentage of participants
Interval 8.52 to 75.51
|
7.7 percentage of participants
Interval 0.19 to 36.03
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 12 Months
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 18 Months
|
—
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Survival Follow Up 24 Months
|
—
|
100 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Cycle 4 Day 1
|
8.7 percentage of participants
Interval 2.42 to 20.79
|
22.9 percentage of participants
Interval 12.03 to 37.31
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Cycle 7 Day 1
|
13.6 percentage of participants
Interval 5.17 to 27.35
|
21.1 percentage of participants
Interval 9.55 to 37.32
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Cycle 13 Day 1
|
9.7 percentage of participants
Interval 2.04 to 25.75
|
25.7 percentage of participants
Interval 12.49 to 43.26
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Cycle 22 Day 1
|
18.8 percentage of participants
Interval 4.05 to 45.65
|
28.0 percentage of participants
Interval 12.07 to 49.39
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Treatment Completion / Early Termination Visit
|
11.1 percentage of participants
Interval 3.71 to 24.05
|
21.4 percentage of participants
Interval 10.3 to 36.81
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 3 Months
|
22.2 percentage of participants
Interval 8.62 to 42.26
|
27.8 percentage of participants
Interval 14.2 to 45.19
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 6 Months
|
6.7 percentage of participants
Interval 0.17 to 31.95
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 9 Months
|
12.5 percentage of participants
Interval 0.32 to 57.87
|
38.5 percentage of participants
Interval 13.86 to 68.42
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 12 Months
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 18 Months
|
—
|
0 percentage of participants
Interval 0.0 to 70.76
|
|
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.
A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=48 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Cycle 4 Day 1
|
19.6 percentage of participants
Interval 9.36 to 33.91
|
33.3 percentage of participants
Interval 20.4 to 48.41
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Cycle 7 Day 1
|
34.1 percentage of participants
Interval 20.49 to 49.92
|
34.2 percentage of participants
Interval 19.63 to 51.35
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Cycle 13 Day 1
|
38.7 percentage of participants
Interval 21.85 to 57.81
|
34.3 percentage of participants
Interval 19.13 to 52.21
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Cycle 22 Day 1
|
43.8 percentage of participants
Interval 19.75 to 70.12
|
44.0 percentage of participants
Interval 24.4 to 65.07
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Treatment Completion / Early Termination Visit
|
31.1 percentage of participants
Interval 18.17 to 46.65
|
40.5 percentage of participants
Interval 25.63 to 56.72
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 3 Months
|
29.6 percentage of participants
Interval 13.75 to 50.18
|
38.9 percentage of participants
Interval 23.14 to 56.54
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 6 Months
|
33.3 percentage of participants
Interval 11.82 to 61.62
|
28.6 percentage of participants
Interval 11.28 to 52.18
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 9 Months
|
12.5 percentage of participants
Interval 0.32 to 52.65
|
23.1 percentage of participants
Interval 5.04 to 53.81
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 12 Months
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 18 Months
|
—
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
|
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Survival Follow Up 24 Months
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)Population: The safety population was defined as participants who received any amount of any component of the study treatments (bevacizumab, paclitaxel or carboplatin). Participants were allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to placebo + chemotherapy alone who received at least one full or partial dose of bevacizumab were included in the bevacizumab + chemotherapy arm for safety).
Outcome measures
| Measure |
Placebo + Paclitaxel + Carboplatin
n=50 Participants
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=49 Participants
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
Placebo + Paclitaxel + Carboplatin
Serious events: 16 serious events
Other events: 49 other events
Deaths: 19 deaths
Bevacizumab + Paclitaxel + Carboplatin
Serious events: 17 serious events
Other events: 49 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Placebo + Paclitaxel + Carboplatin
n=50 participants at risk
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=49 participants at risk
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
3/50 • Number of events 5 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
10.0%
5/50 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Femoral hernia
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.0%
2/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Subileus
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Neutrophil count decreased
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Platelet count decreased
|
10.0%
5/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
Other adverse events
| Measure |
Placebo + Paclitaxel + Carboplatin
n=50 participants at risk
Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
Bevacizumab + Paclitaxel + Carboplatin
n=49 participants at risk
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
35/50 • Number of events 118 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
77.6%
38/49 • Number of events 101 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.0%
14/50 • Number of events 72 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
24.5%
12/49 • Number of events 47 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
10.0%
5/50 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 16 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.0%
7/50 • Number of events 20 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.0%
6/50 • Number of events 25 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Cardiac disorders
Sinus arrhythmia
|
2.0%
1/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
2/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
5/50 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.0%
11/50 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
20.4%
10/49 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.0%
3/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
5/50 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
10/50 • Number of events 26 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
30.6%
15/49 • Number of events 24 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.0%
9/50 • Number of events 12 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 5 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
25/50 • Number of events 62 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
40.8%
20/49 • Number of events 41 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
10.2%
5/49 • Number of events 8 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Gastrointestinal disorders
Vomiting
|
42.0%
21/50 • Number of events 51 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
26.5%
13/49 • Number of events 25 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Asthenia
|
12.0%
6/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 8 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Chest discomfort
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Fatigue
|
4.0%
2/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
14.3%
7/49 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Influenza like illness
|
10.0%
5/50 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
10.2%
5/49 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Malaise
|
12.0%
6/50 • Number of events 21 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
24.5%
12/49 • Number of events 25 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Oedema peripheral
|
4.0%
2/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Pain
|
24.0%
12/50 • Number of events 21 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
10.2%
5/49 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
General disorders
Pyrexia
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
14.0%
7/50 • Number of events 13 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
14.3%
7/49 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
6/50 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
18.4%
9/49 • Number of events 17 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Alanine aminotransferase increased
|
38.0%
19/50 • Number of events 48 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
34.7%
17/49 • Number of events 36 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
14/50 • Number of events 32 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
26.5%
13/49 • Number of events 39 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
4/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
16.3%
8/49 • Number of events 20 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Blood bilirubin increased
|
4.0%
2/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Blood glucose increased
|
6.0%
3/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.0%
3/50 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Blood urea increased
|
4.0%
2/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 14 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Electrocardiogram T wave abnormal
|
2.0%
1/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
10.2%
5/49 • Number of events 21 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
5/50 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
20.4%
10/49 • Number of events 26 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Neutrophil count decreased
|
64.0%
32/50 • Number of events 227 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
79.6%
39/49 • Number of events 250 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Platelet count decreased
|
52.0%
26/50 • Number of events 83 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
59.2%
29/49 • Number of events 88 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Protein urine present
|
4.0%
2/50 • Number of events 5 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
14.3%
7/49 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Red blood cells urine positive
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Urinary occult blood positive
|
10.0%
5/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
0.00%
0/49 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Weight decreased
|
10.0%
5/50 • Number of events 8 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
Weight increased
|
22.0%
11/50 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
14.3%
7/49 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
White blood cell count decreased
|
58.0%
29/50 • Number of events 186 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
77.6%
38/49 • Number of events 226 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Investigations
White blood cells urine positive
|
10.0%
5/50 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
16.3%
8/49 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.0%
7/50 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
28.6%
14/49 • Number of events 28 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.0%
7/50 • Number of events 13 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
20.4%
10/49 • Number of events 17 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.0%
3/50 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
14.3%
7/49 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
5/50 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
8/50 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
16.3%
8/49 • Number of events 11 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
8/50 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.0%
3/50 • Number of events 8 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
4.1%
2/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.0%
3/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.0%
8/50 • Number of events 16 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
22.4%
11/49 • Number of events 15 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Dizziness
|
14.0%
7/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
34.0%
17/50 • Number of events 20 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
34.7%
17/49 • Number of events 24 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Memory impairment
|
8.0%
4/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.0%
6/50 • Number of events 10 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
22.4%
11/49 • Number of events 13 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Psychiatric disorders
Insomnia
|
16.0%
8/50 • Number of events 13 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
20.4%
10/49 • Number of events 23 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
2/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
8.2%
4/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Renal and urinary disorders
Leukocyturia
|
4.0%
2/50 • Number of events 2 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 7 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Renal and urinary disorders
Proteinuria
|
6.0%
3/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
44.9%
22/49 • Number of events 41 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
2.0%
1/49 • Number of events 1 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
12.2%
6/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
82.0%
41/50 • Number of events 43 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
87.8%
43/49 • Number of events 43 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.0%
3/50 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
7/50 • Number of events 9 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
10.2%
5/49 • Number of events 6 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Vascular disorders
Hypertension
|
18.0%
9/50 • Number of events 16 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
36.7%
18/49 • Number of events 65 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.0%
4/50 • Number of events 4 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety population.
|
6.1%
3/49 • Number of events 3 • All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment \& was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, \& were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose \& was included in B+P+C arm in safety 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