Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer (NCT NCT01077713)
NCT ID: NCT01077713
Last Updated: 2015-10-08
Results Overview
Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Month 6
Results posted on
2015-10-08
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Gemcitabine
Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m\^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
36
|
36
|
Reasons for withdrawal
| Measure |
Bevacizumab + Gemcitabine
Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m\^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Progressive Disease (PD)
|
0
|
1
|
|
Overall Study
Death
|
28
|
29
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Other
|
4
|
2
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab + Gemcitabine
n=44 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=42 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 3.2 • n=39 Participants
|
73.8 years
STANDARD_DEVIATION 3.5 • n=41 Participants
|
74.0 years
STANDARD_DEVIATION 3.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
58 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.
Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants Alive and Without Progressive Disease at Month 6
|
25.6 percentage of participants
Interval 12.5 to 38.6
|
30.0 percentage of participants
Interval 15.8 to 44.2
|
SECONDARY outcome
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)Population: ITT set
Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants With Disease Progression or Death
|
86.0 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)Population: ITT set
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.33 months
Interval 2.2 to 5.97
|
6.82 months
Interval 4.49 to 8.52
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT set
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants Alive at 12 Months After Randomization
|
37.2 percentage of participants
Interval 22.8 to 51.7
|
47.5 percentage of participants
Interval 32.0 to 63.0
|
SECONDARY outcome
Timeframe: From randomization to death or end of the study (up to 53 months)Population: ITT set
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants Who Died
|
69.8 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to death or end of the study (up to 53 months)Population: ITT set
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
5.66 months
Interval 3.38 to 13.0
|
12.0 months
Interval 9.93 to 19.6
|
SECONDARY outcome
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)Population: ITT set
Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (\<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants by Best Overall Response
CR
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants by Best Overall Response
PR
|
14.0 percentage of participants
Interval 3.6 to 24.3
|
35.0 percentage of participants
Interval 20.2 to 49.8
|
|
Percentage of Participants by Best Overall Response
SD
|
39.5 percentage of participants
Interval 24.9 to 54.1
|
37.5 percentage of participants
Interval 22.5 to 52.5
|
|
Percentage of Participants by Best Overall Response
PD
|
16.3 percentage of participants
Interval 5.2 to 27.3
|
12.5 percentage of participants
Interval 2.2 to 22.7
|
|
Percentage of Participants by Best Overall Response
Not Assessable
|
30.2 percentage of participants
Interval 16.5 to 44.0
|
15.0 percentage of participants
Interval 3.9 to 26.1
|
SECONDARY outcome
Timeframe: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6Population: ITT set
Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants With an Objective Response
Cycle 3
|
11.6 percentage of participants
Interval 2.05 to 21.2
|
27.5 percentage of participants
Interval 13.7 to 41.3
|
|
Percentage of Participants With an Objective Response
Cycle 6
|
9.3 percentage of participants
Interval 0.62 to 18.0
|
15.0 percentage of participants
Interval 3.93 to 26.1
|
|
Percentage of Participants With an Objective Response
Month 6
|
4.7 percentage of participants
Interval 0.0 to 10.9
|
10.0 percentage of participants
Interval 0.7 to 19.3
|
SECONDARY outcome
Timeframe: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6Population: ITT set
Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Percentage of Participants With Disease Control
Cycle 3
|
53.5 percentage of participants
Interval 38.6 to 68.4
|
67.5 percentage of participants
Interval 53.0 to 82.0
|
|
Percentage of Participants With Disease Control
Cycle 6
|
27.9 percentage of participants
Interval 14.5 to 41.3
|
37.5 percentage of participants
Interval 22.5 to 52.5
|
|
Percentage of Participants With Disease Control
Month 6
|
25.6 percentage of participants
Interval 12.5 to 38.6
|
30.0 percentage of participants
Interval 15.8 to 44.2
|
SECONDARY outcome
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)Population: ITT set.
DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine
n=43 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Duration of Response (DoR)
|
5.23 months
Interval 3.93 to
It was not possible to estimate the statistic using Kaplan-Meier because upper bound of 95% confidence interval was not reached.
|
5.97 months
Interval 2.2 to 9.08
|
Adverse Events
Bevacizumab + Gemcitabine
Serious events: 17 serious events
Other events: 38 other events
Deaths: 0 deaths
Bevacizumab + Gemcitabine + Cisplatin
Serious events: 10 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Gemcitabine
n=43 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Cardiac disorders
Cardiac failure
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
General physical health deterioration
|
4.7%
2/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Pyrexia
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Infections and infestations
Bronchopneumonia
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Nervous system disorders
Aphasia
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
2/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.7%
2/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disease
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.7%
2/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Surgical and medical procedures
Hospitalisation
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Vascular disorders
Embolism
|
2.3%
1/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
2.5%
1/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
Other adverse events
| Measure |
Bevacizumab + Gemcitabine
n=43 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
|
Bevacizumab + Gemcitabine + Cisplatin
n=40 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m\^2 IV infusion on Day 1 and gemcitabine 1000 mg/m\^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
30.0%
12/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
27.5%
11/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.9%
12/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
57.5%
23/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
40.0%
16/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
20.0%
8/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
3/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
12.5%
5/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Nausea
|
18.6%
8/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
42.5%
17/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
15.0%
6/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Asthenia
|
20.9%
9/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
25.0%
10/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Chest pain
|
9.3%
4/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Fatigue
|
18.6%
8/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
37.5%
15/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
12.5%
5/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Pain
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
General disorders
Pyrexia
|
18.6%
8/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
20.0%
8/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
10.0%
4/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Investigations
Platelet count decreased
|
9.3%
4/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
12.5%
5/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
7.5%
3/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
7.5%
3/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
10.0%
4/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
3/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Nervous system disorders
Dizziness
|
7.0%
3/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
20.0%
8/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
0.00%
0/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
15.0%
6/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
4/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
17.5%
7/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
5.0%
2/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.6%
5/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
10.0%
4/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
7.5%
3/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Vascular disorders
Embolism
|
0.00%
0/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
12.5%
5/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
|
Vascular disorders
Hypertension
|
25.6%
11/43 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
22.5%
9/40 • From baseline to 28 days after last dose of any study drug (up to 54 months)
Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
|
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