Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2) (NCT NCT00281697)
NCT ID: NCT00281697
Last Updated: 2013-07-26
Results Overview
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
684 participants
Primary outcome timeframe
Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Results posted on
2013-07-26
Participant Flow
Participant milestones
| Measure |
Standard Chemotherapy + Bevacizumab
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Overall Study
STARTED
|
459
|
225
|
|
Overall Study
COMPLETED
|
58
|
28
|
|
Overall Study
NOT COMPLETED
|
401
|
197
|
Reasons for withdrawal
| Measure |
Standard Chemotherapy + Bevacizumab
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Overall Study
> 60 days since last dose of study drug
|
4
|
4
|
|
Overall Study
Adverse Event
|
54
|
15
|
|
Overall Study
Death
|
8
|
3
|
|
Overall Study
Disease progression
|
279
|
149
|
|
Overall Study
Other
|
5
|
6
|
|
Overall Study
Physician's decision to withdraw
|
15
|
12
|
|
Overall Study
Subject/guardian's decision to withdraw
|
33
|
6
|
|
Overall Study
Did not receive study drug
|
3
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)
Baseline characteristics by cohort
| Measure |
Standard Chemotherapy + Bevacizumab
n=459 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=225 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.6 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
55.0 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
55.4 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
457 Participants
n=99 Participants
|
225 Participants
n=107 Participants
|
682 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=459 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=225 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Progression-free Survival
|
7.2 Months
Interval 6.5 to 7.6
|
5.1 Months
Interval 4.1 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=459 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=225 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Taxanes, n=201, 103
|
8.0 Months
Interval 7.2 to 9.3
|
5.8 Months
Interval 4.2 to 7.9
|
|
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Gemcitabine, n=108, 52
|
6.0 Months
Interval 5.5 to 7.1
|
5.5 Months
Interval 2.6 to 7.5
|
|
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Capecitabine, n=97, 47
|
6.9 Months
Interval 5.5 to 8.5
|
4.1 Months
Interval 2.8 to 5.1
|
|
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Vinorelbine, n=53, 23
|
5.7 Months
Interval 3.5 to 7.5
|
7.0 Months
Interval 2.7 to 8.9
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 6 years, 7 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Overall survival was defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=459 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=225 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Overall Survival
|
18.6 Months
Interval 17.4 to 20.0
|
17.8 Months
Interval 15.1 to 20.4
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 6 years, 7 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Percentage of patients who survived 1 year in the study.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=459 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=225 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
One-year Survival
|
70.5 Percentage of patients
Interval 66.3 to 74.7
|
68.6 Percentage of patients
Interval 62.5 to 74.8
|
SECONDARY outcome
Timeframe: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.
A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=362 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=179 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Objective Response
|
39.5 Percentage of patients
Interval 34.4 to 44.7
|
29.6 Percentage of patients
Interval 23.0 to 36.7
|
SECONDARY outcome
Timeframe: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)Population: Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.
Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.
Outcome measures
| Measure |
Standard Chemotherapy + Bevacizumab
n=143 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=53 Participants
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Duration of Objective Response
|
7.3 Months
Interval 6.2 to 8.2
|
7.5 Months
Interval 6.6 to 9.2
|
Adverse Events
Standard Chemotherapy + Bevacizumab
Serious events: 112 serious events
Other events: 125 other events
Deaths: 0 deaths
Standard Chemotherapy + Placebo
Serious events: 39 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Chemotherapy + Bevacizumab
n=458 participants at risk
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=221 participants at risk
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Gastrointestinal disorders
Periproctitis
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
6/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Nausea
|
0.87%
4/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Constipation
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Colitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Haematemesis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Ileus
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Odynophagia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Proctitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Pneumonia
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
1.4%
3/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Infection
|
0.87%
4/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Cellulitis
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
1.4%
3/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Bronchitis
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Herpes zoster
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Septic shock
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Appendicitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Bronchopneumonia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Device related infection
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Erysipelas
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Rectal abscess
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
8/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
2.3%
5/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
6/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
1.4%
3/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Fascitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Pyrexia
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Asthenia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Chest pain
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Thrombosis in device
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Death
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Impaired healing
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Oedema peripheral
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Pain
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Performance status decreased
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Sudden death
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.87%
4/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Hypertension
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Hypertensive crisis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Hypotension
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Superior vena caval syndrome
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Thrombosis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Syncope
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Tremor
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Altered state of consciousness
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Convulsion
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Headache
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.90%
2/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
5/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Renal and urinary disorders
Renal failure acute
|
0.66%
3/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Renal and urinary disorders
Proteinuria
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.44%
2/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Hepatobiliary disorders
Hepatitis
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Psychiatric disorders
Mental status changes
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Psychiatric disorders
Conversion disorder
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Investigations
Platelet count decreased
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Investigations
Troponin increased
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Eye disorders
Diplopia
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Embolism
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Subcutaneous abscess
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
General disorders
Device dislocation
|
0.22%
1/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.00%
0/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
Other adverse events
| Measure |
Standard Chemotherapy + Bevacizumab
n=458 participants at risk
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Standard Chemotherapy + Placebo
n=221 participants at risk
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
16.8%
77/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
14.9%
33/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.5%
25/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
4.1%
9/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
|
Vascular disorders
Hypertension
|
8.1%
37/458 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
0.45%
1/221 • Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
|
Additional Information
Medical Communications
Genentech, Inc.
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