Trial Outcomes & Findings for A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer (NCT NCT00937560)
NCT ID: NCT00937560
Last Updated: 2017-11-06
Results Overview
Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of each cycle, paclitaxel 80 milligrams per square meters of body surface (mg/m\^2) IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an area under the curve (AUC) of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (milligrams \[mg\] equals \[=\] \[glomerular filtration rate (GFR) + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Initial Treatment
STARTED
|
189
|
|
Initial Treatment
Received Treatment
|
189
|
|
Initial Treatment
COMPLETED
|
168
|
|
Initial Treatment
NOT COMPLETED
|
21
|
|
Maintenance Treatment
STARTED
|
168
|
|
Maintenance Treatment
COMPLETED
|
150
|
|
Maintenance Treatment
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of each cycle, paclitaxel 80 milligrams per square meters of body surface (mg/m\^2) IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an area under the curve (AUC) of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (milligrams \[mg\] equals \[=\] \[glomerular filtration rate (GFR) + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Initial Treatment
Death
|
6
|
|
Initial Treatment
Withdraw consent
|
3
|
|
Initial Treatment
Adverse Event
|
1
|
|
Initial Treatment
Lost to Follow-up
|
1
|
|
Initial Treatment
No end of study page
|
10
|
|
Maintenance Treatment
Death
|
12
|
|
Maintenance Treatment
Withdraw consent
|
5
|
|
Maintenance Treatment
According to protocol
|
1
|
Baseline Characteristics
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Progression-free Survival
|
23.7 Months
Interval 19.9 to 26.4
|
SECONDARY outcome
Timeframe: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=126 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
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|---|---|
|
Percentage of Participants With an Objective Response
RECIST only (N=91)
|
84.6 Percentage of participants
Interval 75.5 to 91.3
|
|
Percentage of Participants With an Objective Response
CA-125 level only (N=101)
|
97.0 Percentage of participants
Interval 91.6 to 99.4
|
|
Percentage of Participants With an Objective Response
RECIST and CA-125 level combined (N=126)
|
92.1 Percentage of participants
Interval 85.9 to 96.1
|
SECONDARY outcome
Timeframe: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=116 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Duration of Response
RECIST only (N=77)
|
14.7 Months
Interval 12.7 to 16.1
|
|
Duration of Response
CA-125 level only (N=98)
|
17.5 Months
Interval 15.4 to 21.9
|
|
Duration of Response
RECIST and CA-125 level combined (N=116)
|
17.4 Months
Interval 15.4 to 21.9
|
SECONDARY outcome
Timeframe: Baseline to Year 2Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Overall Survival at 1 Year and 2 Years
Year 1
|
97.7 Percentage of participants
Interval 95.4 to 99.9
|
|
Overall Survival at 1 Year and 2 Years
Year 2
|
92.1 Percentage of participants
Interval 88.0 to 96.2
|
SECONDARY outcome
Timeframe: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)Population: Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 Participants
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[GFR + 25\] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
|
|---|---|
|
Biological Progression-free Interval
|
NA Months
The median and the limits of the 95% confidence interval could not be calculated due to too few events.
|
Adverse Events
Bevacizumab + Paclitaxel + Carboplatin
Serious events: 43 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 participants at risk
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[glomerular filtration rate + 25\] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion. Paclitaxel: Paclitaxel was supplied locally in commercial batches. Carboplatin: Carboplatin was supplied locally in commercial batches.
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|---|---|
|
Gastrointestinal disorders
Subileus
|
1.6%
3/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.1%
2/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Oesophagits
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Ileus
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Appendicitis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Bacteraemia
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Bacterial sepsis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Catheter site infection
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Cellulitis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Device related infection
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Infected lymphocele
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Pneumonia
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Infections and infestations
Urosepsis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
5/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Nervous system disorders
Syncope
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
2/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Vascular disorders
Deep vein thrombosis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Vascular disorders
Embolism venous
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Vascular disorders
Hypertension
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Vascular disorders
Hypertensive crisis
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
General disorders
Pyrexia
|
1.1%
2/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
General disorders
Chest discomfort
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Cardiac disorders
Atrial fibrillation
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Ear and labyrinth disorders
Deafness
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Immune system disorders
Hypersensitivity
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
|
Renal and urinary disorders
Haematuria
|
0.53%
1/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
|
Other adverse events
| Measure |
Bevacizumab + Paclitaxel + Carboplatin
n=189 participants at risk
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[glomerular filtration rate + 25\] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion. Paclitaxel: Paclitaxel was supplied locally in commercial batches. Carboplatin: Carboplatin was supplied locally in commercial batches.
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Blood and lymphatic system disorders
Neutropenia
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81.0%
153/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Blood and lymphatic system disorders
Thrombocytopenia
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45.0%
85/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Blood and lymphatic system disorders
Anaemia
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58.7%
111/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Blood and lymphatic system disorders
Leukopenia
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25.4%
48/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Blood and lymphatic system disorders
Lymphopenia
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7.4%
14/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Blood and lymphatic system disorders
Thrombocytosis
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5.8%
11/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Nausea
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46.0%
87/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Diarrhoea
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31.2%
59/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Constipation
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33.9%
64/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Stomatitis
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20.6%
39/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Vomiting
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22.8%
43/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Abdominal pain
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16.4%
31/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Abdominal pain upper
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10.6%
20/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Gastrointestinal disorders
Gingival bleeding
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6.9%
13/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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General disorders
Fatigue
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55.6%
105/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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General disorders
Asthenia
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11.6%
22/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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General disorders
Pyrexia
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10.1%
19/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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General disorders
Mucosal inflammation
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7.9%
15/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Nervous system disorders
Peripheral sensory neuropathy
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42.3%
80/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Nervous system disorders
Headache
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18.0%
34/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Nervous system disorders
Paraesthesia
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13.2%
25/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Nervous system disorders
Dysgeusia
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11.6%
22/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Nervous system disorders
Dizziness
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7.4%
14/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Skin and subcutaneous tissue disorders
Alopecia
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47.1%
89/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Skin and subcutaneous tissue disorders
Rash
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8.5%
16/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Skin and subcutaneous tissue disorders
Nail disorder
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7.9%
15/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Skin and subcutaneous tissue disorders
Erythema
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5.3%
10/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Skin and subcutaneous tissue disorders
Nail toxicity
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5.8%
11/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Arthralgia
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22.2%
42/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Myalgia
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14.8%
28/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Musculoskeletal pain
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9.5%
18/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Back pain
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9.5%
18/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Pain in extremity
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5.8%
11/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
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5.3%
10/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Metabolism and nutrition disorders
Hyperglycaemia
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8.5%
16/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Metabolism and nutrition disorders
Decreased appetite
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10.1%
19/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Metabolism and nutrition disorders
Hypokalaemia
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8.5%
16/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Metabolism and nutrition disorders
Hypercholesterolaemia
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6.3%
12/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Metabolism and nutrition disorders
Hypoalbuminemia
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5.8%
11/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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40.2%
76/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Respiratory, thoracic and mediastinal disorders
Dysphonia
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5.3%
10/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Respiratory, thoracic and mediastinal disorders
Cough
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6.9%
13/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Infections and infestations
Urinary tract infection
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11.1%
21/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Infections and infestations
Upper respiratory tract infection
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9.5%
18/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
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9.0%
17/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Vascular disorders
Hypertension
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23.3%
44/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Investigations
Alanine aminotransferase increased
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10.1%
19/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Investigations
Aspartate aminotransferase increased
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7.4%
14/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Renal and urinary disorders
Proteinuria
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5.8%
11/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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Psychiatric disorders
Insomnia
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6.3%
12/189 • Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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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