Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer. (NCT NCT00520403)
NCT ID: NCT00520403
Last Updated: 2014-10-13
Results Overview
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Days 0, 91, 182, 273, 365, 456, and 547
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Bevacizumab + IFN/Vinblastine
STARTED
|
25
|
|
Bevacizumab + IFN/Vinblastine
COMPLETED
|
7
|
|
Bevacizumab + IFN/Vinblastine
NOT COMPLETED
|
18
|
|
Bevacizumab Monotherapy
STARTED
|
2
|
|
Bevacizumab Monotherapy
COMPLETED
|
0
|
|
Bevacizumab Monotherapy
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Bevacizumab + IFN/Vinblastine
Radiological progression of cancer
|
6
|
|
Bevacizumab + IFN/Vinblastine
Adverse Event
|
4
|
|
Bevacizumab + IFN/Vinblastine
Withdrawal of consent
|
4
|
|
Bevacizumab + IFN/Vinblastine
Death
|
2
|
|
Bevacizumab + IFN/Vinblastine
Discontinuation of study/background drug
|
1
|
|
Bevacizumab + IFN/Vinblastine
Protocol Deviation affecting safety
|
1
|
|
Bevacizumab Monotherapy
Radiological progression of cancer
|
1
|
|
Bevacizumab Monotherapy
Symptomatic progression of cancer
|
1
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Baseline characteristics by cohort
| Measure |
Bevacizumab + IFN/Vinblastine
n=25 Participants
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0, 91, 182, 273, 365, 456, and 547Population: Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
Outcome measures
| Measure |
Bevacizumab + IFN/Vinblastine
n=17 Participants
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Percentage of Participants With Disease Progression or Death
|
66.9 percentage of participants
|
PRIMARY outcome
Timeframe: Days 0, 91, 182, 273, 365, 456, and 547Population: ITT population.
PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method
Outcome measures
| Measure |
Bevacizumab + IFN/Vinblastine
n=17 Participants
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
PFS - Time to Event
|
274 days
Standard Error 31.6
|
SECONDARY outcome
Timeframe: Baseline and Cycles 3, 6, 9, 13, and 17Population: ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.
Outcome measures
| Measure |
Bevacizumab + IFN/Vinblastine
n=17 Participants
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Percentage of Participants With Objective Response (OR)
Week 9 (n=14)
|
21.4 percentage of participants
|
|
Percentage of Participants With Objective Response (OR)
Week 18 (n=16)
|
31.3 percentage of participants
|
|
Percentage of Participants With Objective Response (OR)
Week 27 (n=16)
|
37.5 percentage of participants
|
|
Percentage of Participants With Objective Response (OR)
Week 39 (n=16)
|
31.3 percentage of participants
|
|
Percentage of Participants With Objective Response (OR)
Week 51 (n=16)
|
31.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)Population: Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.
OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.
Outcome measures
| Measure |
Bevacizumab + IFN/Vinblastine
n=25 Participants
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Overall Survival (OS)
|
NA weeks
Median could not be calculated due to lack of events as only 2 of 25 participants died during the course of the study.
|
Adverse Events
Bevacizumab + IFN/Vinblastine
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + IFN/Vinblastine
n=25 participants at risk
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Chest Pain
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
General Physical Health Deterioration
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Injection Site Reaction
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Cerebral Haemorrhage
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
Other adverse events
| Measure |
Bevacizumab + IFN/Vinblastine
n=25 participants at risk
Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).
Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.
If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.0%
3/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Cardiac disorders
Arrhythmia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Cardiac disorders
Tachycardia
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Ear and labyrinth disorders
Vertigo
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Ileus paralytic
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Loose tooth
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Nausea
|
28.0%
7/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Periodontitis
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Tongue ulceration
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Toothache
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Asthenia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Chills
|
20.0%
5/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Drug intolerance
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Fatigue
|
40.0%
10/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Impaired healing
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Influenza like illness
|
24.0%
6/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Mucosal inflammation
|
16.0%
4/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
General disorders
Pyrexia
|
12.0%
3/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Infections and infestations
Abscess jaw
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Infections and infestations
Otitis media
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Injury, poisoning and procedural complications
Wound
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Investigations
Blood sodium decreased
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Investigations
Intraocular pressure test
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Investigations
Urine output decreased
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Investigations
Weight decreased
|
12.0%
3/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
10/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
4/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Fascial hernia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.0%
4/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Dysgeusia
|
12.0%
3/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Headache
|
24.0%
6/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Nervous system disorders
Tremor
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Psychiatric disorders
Depressed mood
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Psychiatric disorders
Restlessness
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Psychiatric disorders
Sleep disorder
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Renal and urinary disorders
Proteinuria
|
32.0%
8/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.0%
4/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.0%
6/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
8.0%
2/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Vascular disorders
Haemorrhage
|
4.0%
1/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
|
Vascular disorders
Hypertension
|
24.0%
6/25 • From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER