Trial Outcomes & Findings for Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer (NCT NCT00327171)
NCT ID: NCT00327171
Last Updated: 2016-06-07
Results Overview
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Results posted on
2016-06-07
Participant Flow
218 participants were randomized in this study. Three participants in the 2 mg/kg treatment group did not receive any study medication.
Participant milestones
| Measure |
Aflibercept 2.0 mg/kg
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
108
|
109
|
Reasons for withdrawal
| Measure |
Aflibercept 2.0 mg/kg
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Overall Study
Did not receive study medication
|
3
|
0
|
|
Overall Study
Adverse Event
|
23
|
23
|
|
Overall Study
Disease progression/lack of efficacy
|
68
|
69
|
|
Overall Study
Investigator/participant request
|
1
|
8
|
|
Overall Study
Clinical progression
|
12
|
8
|
|
Overall Study
Undisclosed history of ischemia
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Aflibercept 2.0 mg/kg
n=109 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<35 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
>=35 to <45 years
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
>=45 to <55 years
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
>=55 to <65 years
|
37 participants
n=5 Participants
|
43 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Age, Customized
>=65 to <75 years
|
32 participants
n=5 Participants
|
25 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
104 participants
n=5 Participants
|
107 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Oriental
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Simon's cohort: The first 67 evaluable participants, based on Simon's two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=67 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=67 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=106 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population
|
1 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Simon's cohort: The first 67 evaluable participants, based on Simon's two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.
CBR was defined as having a Stable disease (SD) for \>= 6 months or a confirmed OR (PR or CR). Based on RECIST: * SD was neither a sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), the persistence of non-target lesions or the maintenance of tumor marker level above the normal limits (for non-target lesions) * CR was the disappearance of all target or non-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=67 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=67 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier. Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=1 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=5 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)
|
164 days
Standard Deviation NA
NA: Not calculable since only one participant achieved CR or PR
|
149.8 days
Standard Deviation 70.4
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days.
TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =\< 110% of the post-treatment serum sample.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=61 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=69 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition
|
11.5 percentage of participants
Interval 4.7 to 22.2
|
11.6 percentage of participants
Interval 5.1 to 21.6
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=66 Tumor Progression Events
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=66 Tumor Progression Events
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC
|
13.1 weeks
Interval 12.1 to 16.7
|
12.7 weeks
Interval 12.0 to 18.9
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples).
TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves. For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=15 Tumor Marker Progression events
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=20 Tumor Marker Progression events
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Time to Tumor Marker (CA-125) Progression (TTMP)
|
NA weeks
Interval 24.1 to
The value was not calculable due to the limited number of events.
|
NA weeks
Interval 22.7 to
The value was not calculable due to the limited number of events.
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=106 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.
With disease progression as the first event
|
66 participants
|
66 participants
|
|
Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.
Death without disease progression
|
16 participants
|
23 participants
|
|
Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.
Censored due to drop-out
|
18 participants
|
14 participants
|
|
Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.
Censored at study cut-off
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves. For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=82 PFS Events
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=89 PFS Events
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Progression-free Survival (PFS) Time Based on Analysis by the IRC
|
13.0 weeks
Interval 11.7 to 16.7
|
13.3 weeks
Interval 11.2 to 18.9
|
SECONDARY outcome
Timeframe: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)Population: Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.
OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=50 Events (Death)
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=58 Events (Death)
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Overall Survival (OS) Time
|
59.0 weeks
Interval 41.6 to 84.1
|
49.3 weeks
Interval 37.4 to 62.7
|
SECONDARY outcome
Timeframe: up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse eventPopulation: Safety population: All randomized participants who received at least part of one dose of study treatment.
All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=106 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Overall Safety - Number of Participants With Adverse Events (AE)
With any TEAE
|
106 participants
|
108 participants
|
|
Overall Safety - Number of Participants With Adverse Events (AE)
With any serious TEAE
|
50 participants
|
55 participants
|
|
Overall Safety - Number of Participants With Adverse Events (AE)
With any TEAE leading to death
|
14 participants
|
14 participants
|
|
Overall Safety - Number of Participants With Adverse Events (AE)
With TEAE leading to treatment discontinuation
|
23 participants
|
24 participants
|
SECONDARY outcome
Timeframe: On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2Population: All randomized participants who had evaluable FACT-O questionnaires.
The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome.
Outcome measures
| Measure |
Aflibercept 2.0 mg/kg
n=97 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=104 Participants
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
Change (baseline to Cycle 2-Day 14) (N=79, N=77)
|
-1.1 score on a scale
Standard Deviation 12.7
|
-2.8 score on a scale
Standard Deviation 13.9
|
|
Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
Baseline (N=97, N=104)
|
105.3 score on a scale
Standard Deviation 20.0
|
101.1 score on a scale
Standard Deviation 22
|
Adverse Events
Aflibercept 2.0 mg/kg
Serious events: 51 serious events
Other events: 105 other events
Deaths: 0 deaths
Aflibercept 4.0 mg/kg
Serious events: 56 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept 2.0 mg/kg
n=106 participants at risk
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 participants at risk
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Eye disorders
Blindness transient
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
5.5%
6/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
9.4%
10/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
5.5%
6/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Asthenia
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Disease progression
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Pyrexia
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Sudden death
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Febrile infection
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Hepatitis a
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to small intestine
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
2.8%
3/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
3.7%
4/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.94%
1/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.00%
0/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
5.5%
6/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
0.92%
1/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
Other adverse events
| Measure |
Aflibercept 2.0 mg/kg
n=106 participants at risk
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
|
Aflibercept 4.0 mg/kg
n=109 participants at risk
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
6/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
1.8%
2/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
34.0%
36/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
36.7%
40/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.2%
14/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
15.6%
17/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
34.9%
37/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
24.8%
27/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.2%
31/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
35.8%
39/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
6/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
3.7%
4/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
3.7%
4/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
41.5%
44/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
39.4%
43/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
9.4%
10/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
7.3%
8/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
8.5%
9/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
35.8%
38/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
27.5%
30/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Asthenia
|
28.3%
30/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
24.8%
27/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Fatigue
|
39.6%
42/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
40.4%
44/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
12.3%
13/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
17.4%
19/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
11.3%
12/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
11.0%
12/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
General disorders
Pyrexia
|
17.0%
18/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
19.3%
21/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
7/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
8.3%
9/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
12.3%
13/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
4.6%
5/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Investigations
Weight decreased
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
10.1%
11/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.6%
42/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
27.5%
30/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
8.3%
9/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.6%
25/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
25.7%
28/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.2%
15/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
9.2%
10/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
2/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.2%
15/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
11.9%
13/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
15.6%
17/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
5.5%
6/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
9/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
7.3%
8/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
8.5%
9/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
11.0%
12/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Headache
|
50.9%
54/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
49.5%
54/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
3.7%
4/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.7%
6/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
7.3%
8/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
2.8%
3/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
10.1%
11/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
19.8%
21/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
21.1%
23/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
10/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
19.3%
21/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
36.8%
39/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
42.2%
46/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.2%
15/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
18.3%
20/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
8/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
19.3%
21/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
7/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
10.1%
11/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
6.4%
7/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.8%
4/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
5.5%
6/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
10/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
8.3%
9/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
56.6%
60/106 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
52.3%
57/109 • From treatment initiation to June 9, 2010
Safety population: All randomized participants who received at least part of one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study, for review and comment at least 45 days in advance of any submission, and delay publication till the approval of the publication is given in writing by the Sponsor (not to exceed ninety days).
- Publication restrictions are in place
Restriction type: OTHER