Trial Outcomes & Findings for Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer (NCT NCT01663727)

NCT ID: NCT01663727

Last Updated: 2019-01-22

Results Overview

Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

481 participants

Primary outcome timeframe

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

Results posted on

2019-01-22

Participant Flow

Participant milestones

Participant milestones
Measure
Paclitaxel+Placebo
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Overall Study
STARTED
242
239
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
242
238

Reasons for withdrawal

Reasons for withdrawal
Measure
Paclitaxel+Placebo
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Overall Study
Death
161
155
Overall Study
Lost to Follow-up
10
8
Overall Study
Withdrawal by Subject
18
25
Overall Study
Study Terminated
51
50
Overall Study
Withdrawal by subject and Adverse Event.
1
0
Overall Study
Withdrawal prior to dosing.
1
0

Baseline Characteristics

Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Total
n=481 Participants
Total of all reporting groups
Age, Continuous
54.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
55.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
55.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male
Female
237 Participants
n=5 Participants
236 Participants
n=7 Participants
473 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

Population: ITT population.

Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population
69.4 percentage of participants
63.6 percentage of participants

PRIMARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

Population: ITT population.

PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Progression Free Survival (PFS) in ITT Population
8.8 months
Interval 7.4 to 9.3
11.0 months
Interval 9.5 to 12.2

PRIMARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

Population: High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.

Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=124 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=120 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population
75.0 percentage of participants
70.8 percentage of participants

PRIMARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

Population: High baseline plasma VEGF-A ITT population.

PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=124 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=120 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
PFS in High Baseline Plasma VEGF-A ITT Population
7.3 months
Interval 5.6 to 8.7
9.6 months
Interval 9.0 to 11.0

SECONDARY outcome

Timeframe: From randomization till death or clinical cut-off (up to 244 weeks)

Population: ITT Population.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants Who Died - ITT Population
64.9 percentage of participants
64.0 percentage of participants

SECONDARY outcome

Timeframe: From randomization till death or clinical cut-off (up to 244 weeks)

Population: ITT population.

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Overall Survival (OS) - ITT Population
25.8 months
Interval 21.8 to 30.2
28.8 months
Interval 22.8 to 32.8

SECONDARY outcome

Timeframe: From randomization till death or clinical cut-off (up to 244 weeks)

Population: High Baseline Plasma VEGF-A ITT Population.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=124 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=120 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population
74.2 percentage of participants
71.1 percentage of participants

SECONDARY outcome

Timeframe: From randomization till death or clinical cut-off (up to 244 weeks)

Population: High Baseline Plasma VEGF-A ITT population.

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=124 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=120 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OS - High Baseline Plasma VEGF-A ITT Population
19.4 months
Interval 16.5 to 25.0
22.8 months
Interval 18.2 to 31.6

SECONDARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

Population: Number of participants analyzed=participants from ITT population with measurable disease at baseline.

Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=214 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=202 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants With an Objective Response - ITT Population
33.2 percentage of participants
Interval 26.87 to 39.49
54.0 percentage of participants
Interval 47.09 to 60.83

SECONDARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

Population: Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.

Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=116 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=105 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population
32.8 percentage of participants
Interval 24.22 to 41.3
54.3 percentage of participants
Interval 44.76 to 63.81

SECONDARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)

Population: Number of participants analyzed=participants from ITT population who had an objective response.

Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=71 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=109 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Duration of Response - ITT Population
9.2 months
Interval 7.4 to 11.5
9.5 months
Interval 7.8 to 12.4

SECONDARY outcome

Timeframe: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)

Population: Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.

Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=38 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=57 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Duration of Response - High Baseline Plasma VEGF-A ITT Population
7.2 months
Interval 5.6 to 9.5
8.1 months
Interval 7.1 to 11.1

SECONDARY outcome

Timeframe: 1 year

Population: ITT Population.

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=242 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=239 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Percentage of Participants Who Were Alive at 1 Year - ITT Population
80.94 percentage of participants
82.47 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: High Baseline Plasma VEGF-A ITT Population

Outcome measures

Outcome measures
Measure
Paclitaxel+Placebo
n=124 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=120 Participants
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population
69.27 percentage of participants
80.96 percentage of participants

Adverse Events

Paclitaxel+Placebo

Serious events: 45 serious events
Other events: 225 other events
Deaths: 162 deaths

Paclitaxel+ Bevacizumab

Serious events: 66 serious events
Other events: 230 other events
Deaths: 161 deaths

Serious adverse events

Serious adverse events
Measure
Paclitaxel+Placebo
n=233 participants at risk
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=238 participants at risk
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Anaemia
0.86%
2/233 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Leukopenia
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Neutropenia
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Cardiac disorders
Atrial fibrillation
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Cardiac disorders
Left ventricular dysfunction
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Eye disorders
Optic nerve disorder
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Eye disorders
Visual acuity reduced
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Abdominal distension
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Abdominal pain
1.7%
4/233 • Number of events 6 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Colitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Constipation
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Diarrhoea
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Duodenal obstruction
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Dyspepsia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Enteritis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Gastric ulcer
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Gastric varices haemorrhage
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Haematochezia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Nausea
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Pancreatitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Vomiting
1.3%
3/233 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Asthenia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Death
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Influenza like illness
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Malaise
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Mucosal inflammation
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Pyrexia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Sudden death
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Cholecystitis
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Cholecystitis acute
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Gallbladder pain
0.43%
1/233 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Hepatic failure
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.3%
3/238 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Immune system disorders
Drug hypersensitivity
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Abdominal wall abscess
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Abscess
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Abscess limb
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Appendicitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Cellulitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 6 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Cholecystitis infective
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Colonic abscess
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Cystitis
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Device related infection
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.3%
3/238 • Number of events 3 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Device related sepsis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Gastroenteritis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Infection
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Influenza
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Lung infection
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Peritonitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Pharyngotonsillitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Pneumonia
1.3%
3/233 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Pneumonia necrotising
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Sepsis
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Sepsis syndrome
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Septic shock
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Upper respiratory tract infection
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Urinary tract infection
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Wound infection bacterial
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
Hip fracture
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.84%
2/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
Urine output decreased
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
Decreased appetite
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Cerebral ischaemia
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Dementia
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Dizziness
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Hemiparesis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Loss of consciousness
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Speech disorder
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Spinal cord compression
0.43%
1/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Syncope
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.3%
3/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Renal and urinary disorders
Cystitis haemorrhagic
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Renal and urinary disorders
Haematuria
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
1.7%
4/238 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Pain of skin
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Skin haemorrhage
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Aortic stenosis
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Deep vein thrombosis
0.86%
2/233 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Embolism venous
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Superior vena cava syndrome
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Venous thrombosis limb
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Cardiac disorders
ACUTE CORONARY SYNDROME
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Eye disorders
CATARACT
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
CATHETER SITE ERYTHEMA
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 2 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Immune system disorders
ANAPHYLACTIC REACTION
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
VIRAL INFECTION
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
CATHETER SITE INFECTION
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
KLEBSIELLA SEPSIS
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
SOFT TISSUE INFECTION
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
0.43%
1/233 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.00%
0/238 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
STERNAL FRACTURE
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Injury, poisoning and procedural complications
WOUND DEHISCENCE
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
HYPONATRAEMIA
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
LACTIC ACIDOSIS
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
ARTERIAL THROMBOSIS
0.00%
0/233 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
0.42%
1/238 • Number of events 1 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).

Other adverse events

Other adverse events
Measure
Paclitaxel+Placebo
n=233 participants at risk
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Paclitaxel+ Bevacizumab
n=238 participants at risk
Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
Blood and lymphatic system disorders
Anaemia
16.7%
39/233 • Number of events 82 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
16.4%
39/238 • Number of events 63 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Leukopenia
6.0%
14/233 • Number of events 42 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
7.1%
17/238 • Number of events 41 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Blood and lymphatic system disorders
Neutropenia
21.5%
50/233 • Number of events 124 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
32.4%
77/238 • Number of events 254 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Abdominal pain
7.3%
17/233 • Number of events 30 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.4%
20/238 • Number of events 27 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Abdominal pain upper
5.6%
13/233 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.5%
13/238 • Number of events 16 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Constipation
21.5%
50/233 • Number of events 70 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
28.2%
67/238 • Number of events 108 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Diarrhoea
30.9%
72/233 • Number of events 128 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
37.0%
88/238 • Number of events 189 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Dyspepsia
6.9%
16/233 • Number of events 20 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
9.7%
23/238 • Number of events 40 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Nausea
32.2%
75/233 • Number of events 205 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
41.6%
99/238 • Number of events 310 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Stomatitis
11.2%
26/233 • Number of events 35 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
17.6%
42/238 • Number of events 75 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Toothache
3.4%
8/233 • Number of events 9 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 16 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Gastrointestinal disorders
Vomiting
15.5%
36/233 • Number of events 63 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
19.7%
47/238 • Number of events 96 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Asthenia
15.5%
36/233 • Number of events 50 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
13.4%
32/238 • Number of events 62 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Fatigue
31.8%
74/233 • Number of events 123 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
37.0%
88/238 • Number of events 156 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Oedema peripheral
18.0%
42/233 • Number of events 57 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
17.2%
41/238 • Number of events 56 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
General disorders
Pyrexia
12.0%
28/233 • Number of events 37 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
14.3%
34/238 • Number of events 59 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Bronchitis
5.2%
12/233 • Number of events 12 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
4.6%
11/238 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Nasopharyngitis
15.5%
36/233 • Number of events 65 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
10.1%
24/238 • Number of events 54 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Paronychia
3.0%
7/233 • Number of events 9 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.5%
13/238 • Number of events 13 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Upper respiratory tract infection
4.7%
11/233 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
10.5%
25/238 • Number of events 26 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
Urinary tract infection
6.9%
16/233 • Number of events 22 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
14.7%
35/238 • Number of events 47 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
Alanine aminotransferase increased
7.3%
17/233 • Number of events 21 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.8%
21/238 • Number of events 37 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
Aspartate aminotransferase increased
6.9%
16/233 • Number of events 19 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.8%
21/238 • Number of events 32 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
Neutrophil count decreased
8.6%
20/233 • Number of events 100 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 56 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
White blood cell count decreased
6.9%
16/233 • Number of events 84 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.8%
21/238 • Number of events 87 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
Decreased appetite
18.0%
42/233 • Number of events 65 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
23.1%
55/238 • Number of events 91 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Metabolism and nutrition disorders
Hypokalaemia
4.3%
10/233 • Number of events 13 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 22 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Arthralgia
22.7%
53/233 • Number of events 86 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
22.3%
53/238 • Number of events 91 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Back pain
13.3%
31/233 • Number of events 42 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
10.9%
26/238 • Number of events 32 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Bone pain
8.6%
20/233 • Number of events 32 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
4.6%
11/238 • Number of events 17 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Myalgia
12.0%
28/233 • Number of events 60 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
18.1%
43/238 • Number of events 83 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
Pain in extremity
9.0%
21/233 • Number of events 23 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
9.7%
23/238 • Number of events 32 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Dizziness
10.3%
24/233 • Number of events 25 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
11.8%
28/238 • Number of events 33 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Dysgeusia
9.4%
22/233 • Number of events 24 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
13.9%
33/238 • Number of events 43 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Headache
18.9%
44/233 • Number of events 71 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
21.4%
51/238 • Number of events 85 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Neuropathy peripheral
21.5%
50/233 • Number of events 67 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
19.7%
47/238 • Number of events 72 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Paraesthesia
7.3%
17/233 • Number of events 21 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.0%
12/238 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Nervous system disorders
Peripheral sensory neuropathy
36.1%
84/233 • Number of events 107 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
38.7%
92/238 • Number of events 129 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Psychiatric disorders
Anxiety
6.4%
15/233 • Number of events 15 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
3.4%
8/238 • Number of events 8 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Psychiatric disorders
Insomnia
8.6%
20/233 • Number of events 24 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
14.7%
35/238 • Number of events 46 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Renal and urinary disorders
Proteinuria
11.2%
26/233 • Number of events 33 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
13.4%
32/238 • Number of events 53 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Cough
12.9%
30/233 • Number of events 38 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
18.1%
43/238 • Number of events 59 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Dysphonia
2.1%
5/233 • Number of events 5 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.0%
19/238 • Number of events 24 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
12.9%
30/233 • Number of events 33 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
13.9%
33/238 • Number of events 41 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Epistaxis
20.6%
48/233 • Number of events 77 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
40.8%
97/238 • Number of events 158 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
6.0%
14/233 • Number of events 15 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
7.6%
18/238 • Number of events 23 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
1.3%
3/233 • Number of events 4 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
8.4%
20/238 • Number of events 26 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Alopecia
62.2%
145/233 • Number of events 159 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
58.8%
140/238 • Number of events 149 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Dry skin
3.0%
7/233 • Number of events 7 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
7.6%
18/238 • Number of events 20 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Nail discolouration
7.7%
18/233 • Number of events 18 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
13.9%
33/238 • Number of events 37 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Nail disorder
5.6%
13/233 • Number of events 13 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.5%
13/238 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Onychomadesis
2.6%
6/233 • Number of events 6 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 17 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Pruritis
4.3%
10/233 • Number of events 12 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 17 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Skin and subcutaneous tissue disorders
Rash
13.3%
31/233 • Number of events 36 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
24.4%
58/238 • Number of events 113 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Hot flush
4.3%
10/233 • Number of events 30 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
6.3%
15/238 • Number of events 17 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Vascular disorders
Hypertension
12.9%
30/233 • Number of events 83 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
30.7%
73/238 • Number of events 109 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Infections and infestations
SINUSITIS
3.4%
8/233 • Number of events 12 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.0%
12/238 • Number of events 15 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Investigations
WEIGHT DECREASED
2.1%
5/233 • Number of events 5 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.0%
12/238 • Number of events 13 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
NECK PAIN
1.3%
3/233 • Number of events 5 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.0%
12/238 • Number of events 13 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
2.1%
5/233 • Number of events 8 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
5.0%
12/238 • Number of events 14 • From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800 821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER