Trial Outcomes & Findings for A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer (NCT NCT00887822)
NCT ID: NCT00887822
Last Updated: 2017-03-01
Results Overview
Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
From randomization until death (up to 34 months)
Results posted on
2017-03-01
Participant Flow
Study reported data up to clinical cut-off date 13 May 2011, as approximately half of the participants withdrew the study at clinical cut-off date. Ad hoc analysis was done for overall survival, with clinical cut-off date of 12 January 2012, subsequent to clinical cut-off date of 13 May 2011.
Participant milestones
| Measure |
Bevacizumab, Capecitabine and Cisplatin
Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
102
|
|
Overall Study
Treated (Safety Population)
|
100
|
101
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
97
|
102
|
Reasons for withdrawal
| Measure |
Bevacizumab, Capecitabine and Cisplatin
Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Overall Study
Insufficient therapeutic response
|
53
|
55
|
|
Overall Study
Adverse Event
|
14
|
17
|
|
Overall Study
Failure to return
|
11
|
11
|
|
Overall Study
Refused treatment/Did not cooperate
|
12
|
10
|
|
Overall Study
Administrative/Other than specified
|
5
|
4
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
Baseline Characteristics
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Gender
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Gender
Male
|
68 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until death (up to 34 months)Population: ITT population
Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With Event (Death)
|
77.0 percentage of participants
|
75.5 percentage of participants
|
PRIMARY outcome
Timeframe: From randomization until death (up to 34 months)Population: ITT population
Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Overall Survival
|
10.5 months
Interval 8.9 to 14.1
|
11.4 months
Interval 8.6 to 14.6
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
Progression of disease was defined as at least 20 percent (%) increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 millimeters (mm), progression of existing non-target lesions, or presence of new lesions. PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to Response Evaluation Criteria In Solid Tumors (RECIST).
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)
|
81.0 percentage of participants
|
81.4 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to RECIST. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest 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. Reported data included censored observations. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
6.3 months
Interval 5.7 to 7.4
|
6.0 months
Interval 4.9 to 7.4
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS during first-line therapy was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last confirmed intake of any study medication and before the start of non-study antineoplastic treatment, according to RECIST.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy
|
51.0 percentage of participants
|
59.8 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population.
PFS during first-line therapy was defined as time between randomization and date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last intake of any study medication and only if it occurred before start of non-study antineoplastic treatment, according to RECIST. Progression of disease was defined as at least 20% increase in sum of longest diameters of target lesions compared to smallest sum of longest diameters on-study \& 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. Reported data included censored observations. Participants who neither progressed nor died in this interval, or who were lost to follow-up were censored at date of last tumor assessment/last follow-up within this time window. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
PFS During First-line Therapy
|
6.3 months
Interval 5.7 to 7.5
|
6.1 months
Interval 5.5 to 7.6
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest 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, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With Disease Progression
|
56.0 percentage of participants
|
53.9 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
Time to progression was defined as the time between randomization and the first occurrence of disease progression. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Time to progression was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had not progressed at the time of study completion (including participants who had died before disease progression) or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Time to Progression
|
6.5 months
Interval 5.7 to 7.5
|
7.0 months
Interval 5.8 to 8.5
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: Measurable disease population included all randomized participants who had measurable disease at baseline according to RECIST.
Best overall response during first-line therapy was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR), as assessed by the RECIST criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=81 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=86 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy
|
40.7 percentage of participants
Interval 29.9 to 52.2
|
33.7 percentage of participants
Interval 23.9 to 44.7
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: Measurable disease population
Duration of response during first-line therapy was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first-line therapy. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. Duration of response was estimated using Kaplan Meier method. Reported data included censored observations. Participants who did not progress or die after they had had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=81 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=86 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Duration of Response During First-Line Therapy
|
7.2 months
Interval 4.9 to 11.3
|
5.8 months
Interval 4.6 to 6.6
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death (up to 26 months)Population: ITT population
Disease control was defined as stable disease(SD) for 6 weeks or longer, CR plus PR as assessed by RECIST criteria for participants with measurable disease.CR:disappearance of all TLs \& normalization of tumor markers. Pathological lymph nodes must have short axis measures\<10 mm. PR:at least 30% decrease in sum of measures(longest diameter for tumor lesions and short axis measure for nodes)of TLs, taking as reference baseline sum of longest diameters.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression taking as reference smallest sum of longest diameters on study. For participants without measurable disease, clinical benefit rate was defined as no clinical disease progression for \>/=6 weeks. Disease progression was defined as at least 20% increase in sum of diameters of TLs 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, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Percentage of Participants With Disease Control During First-Line Therapy
|
73.0 percentage of participants
Interval 63.2 to 81.4
|
72.5 percentage of participants
Interval 62.8 to 80.9
|
SECONDARY outcome
Timeframe: From Cycle 1 until disease progression (up to 26 months)Population: ITT population
EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Role Functioning
|
-0.65 scores on scale
Interval -1.46 to 0.17
|
-0.37 scores on scale
Interval -1.19 to 0.46
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Fatigue
|
-0.36 scores on scale
Interval -1.14 to 0.43
|
-0.27 scores on scale
Interval -1.07 to 0.53
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Dyspnoea
|
-0.10 scores on scale
Interval -0.48 to 0.27
|
-0.07 scores on scale
Interval -0.47 to 0.32
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Constipation
|
-0.14 scores on scale
Interval -0.62 to 0.34
|
-0.02 scores on scale
Interval -0.58 to 0.54
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
GHS/QOL
|
1.24 scores on scale
Interval 0.7 to 1.78
|
0.73 scores on scale
Interval 0.15 to 1.31
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Physical Funtioning
|
-0.89 scores on scale
Interval -1.66 to -0.12
|
-0.99 scores on scale
Interval -1.77 to -0.21
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Emotional Functioning
|
-0.22 scores on scale
Interval -0.87 to 0.44
|
0.19 scores on scale
Interval -0.47 to 0.85
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Cognitive Functioning
|
-0.51 scores on scale
Interval -1.09 to 0.07
|
-0.41 scores on scale
Interval -1.0 to 0.18
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Social Functioning
|
-0.27 scores on scale
Interval -1.02 to 0.48
|
0.08 scores on scale
Interval -0.68 to 0.85
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Nausea and Vomiting
|
-0.82 scores on scale
Interval -1.26 to -0.38
|
-0.55 scores on scale
Interval -1.05 to -0.05
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Pain
|
-0.55 scores on scale
Interval -1.13 to 0.03
|
-0.22 scores on scale
Interval -0.83 to 0.38
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Insomnia
|
-0.57 scores on scale
Interval -1.04 to -0.09
|
0.26 scores on scale
Interval -0.28 to 0.8
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Appetite Loss
|
-0.65 scores on scale
Interval -1.25 to -0.05
|
-1.17 scores on scale
Interval -1.83 to -0.51
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Diarrhoea
|
-0.29 scores on scale
Interval -0.69 to 0.11
|
0.00 scores on scale
Interval -0.44 to 0.45
|
|
Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
Financial Difficulties
|
0.31 scores on scale
Interval -0.57 to 1.19
|
0.04 scores on scale
Interval -0.86 to 0.94
|
SECONDARY outcome
Timeframe: From Cycle 1 until disease progression (up to 26 months)Population: ITT population
The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 Participants
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=102 Participants
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Pain
|
-0.97 scores on scale
Interval -1.5 to -0.43
|
-0.52 scores on scale
Interval -1.07 to 0.03
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Dysphagia
|
-0.31 scores on scale
Interval -0.63 to 0.02
|
-0.05 scores on scale
Interval -0.4 to 0.3
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Reflux Symptoms
|
-0.27 scores on scale
Interval -0.78 to 0.24
|
-0.43 scores on scale
Interval -0.95 to 0.09
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Eating Restrictions
|
-0.30 scores on scale
Interval -0.75 to 0.15
|
-0.36 scores on scale
Interval -0.83 to 0.1
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Anxiety
|
-0.17 scores on scale
Interval -0.91 to 0.57
|
-0.73 scores on scale
Interval -1.48 to 0.03
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Dry Mouth
|
-0.19 scores on scale
Interval -0.94 to 0.55
|
0.68 scores on scale
Interval -0.08 to 1.44
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Taste
|
-0.44 scores on scale
Interval -1.05 to 0.16
|
-0.66 scores on scale
Interval -1.29 to -0.02
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Body Image
|
0.27 scores on scale
Interval -0.52 to 1.05
|
0.13 scores on scale
Interval -0.68 to 0.94
|
|
Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
Hair Loss
|
-0.35 scores on scale
Interval -1.29 to 0.58
|
-0.61 scores on scale
Interval -1.73 to 0.5
|
Adverse Events
Bevacizumab, Capecitabine and Cisplatin
Serious events: 19 serious events
Other events: 94 other events
Deaths: 0 deaths
Placebo, Capecitabine and Cisplatin
Serious events: 21 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=101 participants at risk
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
6.9%
7/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.0%
4/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
3.0%
3/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Gastropleural fistula
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
2.0%
2/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Epilepsy
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Infections and infestations
Lung infection
|
3.0%
3/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Infections and infestations
Meningitis
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
General disorders
Death
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.99%
1/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
Other adverse events
| Measure |
Bevacizumab, Capecitabine and Cisplatin
n=100 participants at risk
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
Placebo, Capecitabine and Cisplatin
n=101 participants at risk
Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
59.0%
59/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
55.4%
56/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
61.0%
61/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
52.5%
53/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Constipation
|
18.0%
18/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
23.8%
24/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
14/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
11.9%
12/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
14/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
8.9%
9/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
7/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
8.9%
9/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.0%
38/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
39.6%
40/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.0%
31/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
34.7%
35/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.0%
11/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
13.9%
14/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
6/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
12.9%
13/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
3.0%
3/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
5.9%
6/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Neutrophil count decreased
|
29.0%
29/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
27.7%
28/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
White blood cell count decreased
|
15.0%
15/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
23.8%
24/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Platelet count decreased
|
19.0%
19/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
12.9%
13/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Haemoglobin decreased
|
10.0%
10/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
9.9%
10/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
7/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
5.9%
6/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
6/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
5.9%
6/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Blood bilirubin increased
|
7.0%
7/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
4.0%
4/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Investigations
Creatinine renal clearance decreased
|
1.0%
1/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
5.9%
6/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.0%
32/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
35.6%
36/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.0%
11/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
11.9%
12/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
5/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
4.0%
4/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
General disorders
Fatigue
|
24.0%
24/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
23.8%
24/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
General disorders
Pyrexia
|
14.0%
14/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
12.9%
13/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
17.0%
17/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
8.9%
9/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Vascular disorders
Hypertension
|
12.0%
12/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
6.9%
7/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
6/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
4.0%
4/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
5/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
|
Nervous system disorders
Headache
|
7.0%
7/100 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
0.00%
0/101 • From randomization up to 26 months
Safety population included all randomized participants who received at least one dose/infusion of any component of study medication.
|
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