Trial Outcomes & Findings for OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum. (NCT NCT00577031)
NCT ID: NCT00577031
Last Updated: 2015-08-18
Results Overview
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
205 participants
Primary outcome timeframe
Baseline and Day 1 of every cycle until disease progression or death up to 5 years
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m\^2) IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
205
|
Reasons for withdrawal
| Measure |
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m\^2) IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Overall Study
Adverse Event
|
52
|
|
Overall Study
Progression of disease
|
93
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Participant withdrew consent
|
13
|
|
Overall Study
Participant non-compliance
|
5
|
|
Overall Study
Need for surgery
|
17
|
|
Overall Study
Medical decision
|
14
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
Baseline characteristics by cohort
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Age, Continuous
|
62.25 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of every cycle until disease progression or death up to 5 yearsPopulation: Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of all study medications and had at least 1 measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death
|
50.25 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of every cycle until disease progression or death up to 5 yearsPopulation: ITT population.
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
PFS: Time to Event
|
9.70 months
Interval 8.43 to 10.49
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 yearsPopulation: Subset of participants in the ITT population who had at least 1 post-baseline tumor assessment.
The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=165 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment
|
58.79 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 yearsPopulation: ITT population.
CR and PR were defined using RECIST v1.0. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis \<10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With a CR or PR Among Participants in the ITT Population
|
49.24 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 yearsPopulation: ITT population.
Time to overall response (CR or PR) was calculated as the time between the date of start of treatment until first documented response (CR or PR defined per RECIST v1.0). Participants who did not achieve CR or PR were censored at the date of progression, death, or at last adequate tumor assessment date. Median time to CR or PR overall response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Time to CR or PR Overall Response - Time to Event
|
3.93 months
Interval 2.56 to 4.66
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.
CR and PR were defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis \<10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=97 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment
|
54.64 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.
For participants with a best overall response of CR or PR, the duration of overall response was measured from the time that the criteria for CR or PR (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of overall response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=97 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event
|
8.52 months
Interval 7.28 to 10.33
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.
Stable response defined as participants with a best overall response of CR, PR, or stable disease (SD), defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis \<10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=152 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With a Stable Response During First Line Treatment
|
52.63 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.
For participants with a best overall response of CR, PR, or SD during first line treatment, the duration of stable response was measured from the time that the criteria for CR, PR, or SD (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of stable response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=152 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Duration of Stable Response
|
10.39 months
Interval 9.02 to 11.44
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population.
Treatment-failure was defined as discontinuation of treatment for any reason, including the following qualifying events: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With Treatment Failure
|
82.74 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 yearsPopulation: ITT population.
Time to treatment-failure was defined as the time from the first day of treatment to discontinuation of treatment for any reason, including: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). For participants who did not experience a qualifying event, their data were censored at the earlier of either the date of last tumour assessment or the date of the last intake of study medication. Median time to treatment-failure was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Time to Treatment Failure
|
6.69 months
Interval 5.97 to 7.74
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 yearsPopulation: ITT population.
Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Overall Survival: Percentage of Participants That Died Due to Any Cause
|
50.76 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 yearsPopulation: ITT population.
Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive. Median overall survival was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Overall Survival: Time to Event
|
23.15 months
Interval 20.07 to 27.15
|
SECONDARY outcome
Timeframe: At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 yearsPopulation: The 52 participant subpopulation of the ITT population who underwent surgery during the time period of the study.
The percentage of participants who underwent surgery during the study period with an evaluation of their disease status after surgery. The surgery during the study period was described by reason: curative, palliative, biopsy, other, or unknown. Residual disease status after surgery was described as: no residual disease due to radical surgery, presence of residual disease, unknown or not applicable.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=52 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Curative, no residual disease
|
55.77 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Curative, residual disease
|
13.46 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Curative, unknown
|
3.85 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Curative, not applicable
|
7.69 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Palliative, no residual disease
|
3.85 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Palliative, residual disease
|
7.69 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Palliative, unknown
|
3.85 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Palliative, not applicable
|
1.92 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Biopsy, residual disease
|
1.92 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Biopsy, not applicable
|
1.92 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Unknown, unknown
|
1.92 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Unknown, not applicable
|
3.85 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Other, residual disease
|
1.92 percentage of participants
|
|
Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
Other, not applicable
|
3.85 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 yearsPopulation: ITT population; only participants with a known K-Ras and/or B-Raf gene mutation status and at least 1 post-baseline tumor assessment. Number (n) equals (=) number of participants with either wild-type or K-Ras/B-Raf gene mutation.
The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis \<10 mm). No new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. The K-Ras and/or the B-Raf gene mutation status of participants was evaluated by the central laboratory using tumor samples. Wild-type participants did not have a mutation in either gene.
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=33 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status
Wild-type (n=18)
|
88.89 percentage of participants
|
|
Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status
Gene mutation (n=15)
|
66.67 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 yearsPopulation: ITT population, only participants who had EQ-5D-3L scores for both baseline and last visit were included in the analysis.
Quality of life (QoL) assessments were used to derive pre-specified QoL scores according to the QoL manual "EQ-5D-3 Level (3L)" user guide for instrument version 4.0. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The visual analog scale (VAS) component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The overall health score absolute changes were calculated for each participant as follows: (score at the end of treatment minus score at baseline). EQ-5D health states were converted into EQ-5D-3L raw index value by applying the scoring algorithm based on the European EQ-net VAS set. The raw index was chosen instead of rescaled index, since the questionnaire was used in order to obtain a quality of life assessment. The raw index scores ranged from 0 (worst health state) to 100 (best health state).
Outcome measures
| Measure |
Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab
n=114 Participants
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score
Baseline
|
80.24 units on a scale
Standard Deviation 14.32
|
|
European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score
Last visit
|
74.94 units on a scale
Standard Deviation 19.08
|
|
European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score
Absolute change from baseline
|
-5.30 units on a scale
Standard Deviation 19.13
|
Adverse Events
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab
Serious events: 56 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 participants at risk
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Subileus
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Asthenia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Immune system disorders
Hypersensitivity
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Pneumonia
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Cachexia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hypertensive crisis
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hypertension
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Surgical and medical procedures
Vertebroplasty
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Cardiovascular disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Peritonitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Chest pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Death
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Fatigue
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Ill-defined disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Pyrexia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Immune system disorders
Anaphylactic shock
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Abscess
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Bronchitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Psoas abscess
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Renal abscess
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Sepsis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Tuberculosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Hemiparesis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Neurotoxicity
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Syncope
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
Other adverse events
| Measure |
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab
n=197 participants at risk
Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m\^2 IV on Day 1 and capecitabine 1000 mg/m\^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.
Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
11/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.6%
13/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.2%
32/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.2%
26/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
14.7%
29/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
12/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.7%
27/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
37.1%
73/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
42.6%
84/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
10/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
48/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Asthenia
|
30.5%
60/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Fatigue
|
14.7%
29/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Mucosal inflammation
|
10.7%
21/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Pyrexia
|
20.3%
40/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
18/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
10/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
16/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Headache
|
5.1%
10/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
19.3%
38/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Neurotoxicity
|
5.6%
11/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Paraesthesia
|
29.9%
59/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
8.6%
17/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
12/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
14/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.1%
18/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hypertension
|
22.8%
45/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Cardiac ventricular disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Palpitations
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Cardiac disorders
Tachycardia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Congenital, familial and genetic disorders
Dihydropyrimidine dehydrogenase deficiency
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Ear and labyrinth disorders
Deafness
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
4.1%
8/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Conjunctivitis
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Diplopia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Eye irritation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Eye pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Lacrimation increased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Eye disorders
Scleral haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Anal inflammation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Dental discomfort
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Enteritis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Enterocolitis haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Gingivitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Proctalgia
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Subileus
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Gastrointestinal disorders
Tooth disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Chest pain
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Discomfort
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Facial pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Hyperpyrexia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Infusion site extravasation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Infusion site pain
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Injection site haematoma
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Oedema
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Oedema peripheral
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Pain
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
General disorders
Performance status decreased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.0%
6/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Immune system disorders
Drug hypersensitivity
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Immune system disorders
Hypersensitivity
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Bronchitis
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Cystitis
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Ear infection
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Folliculitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Fungal infection
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Herpes virus infection
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Infection
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Influenza
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Labyrinthitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Pharyngitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Pneumonia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Psoas abscess
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Rhinitis
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Tooth abscess
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complications
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood bilirubin increased
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood creatinine increased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood iron decreased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Blood uric acid increased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Haemoglobin decreased
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Weight decreased
|
4.1%
8/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Investigations
Weight increased
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Cachexia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Gout
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.1%
8/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
6/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
6/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Dizziness
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Dysaesthesia
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
4.6%
9/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Migraine
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Neuralgia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Presyncope
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Sciatica
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Syncope
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Syncope vasovagal
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Nervous system disorders
Tremor
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Psychiatric disorders
Anxiety
|
3.0%
6/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Psychiatric disorders
Depression
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Psychiatric disorders
Mood altered
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Dysuria
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Haematuria
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Nocturia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Renal and urinary disorders
Strangury
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Reproductive system and breast disorders
Balanitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Reproductive system and breast disorders
Orchitis noninfective
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
7/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Larynx irritation
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal spasm
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
3/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Surgical and medical procedures
Cyst drainage
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Aortic thrombosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Axillary vein thrombosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Blood pressure fluctuation
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hot flush
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hypertensive crisis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Hypotension
|
2.5%
5/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Lymphoedema
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Phlebitis
|
2.0%
4/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Thrombophlebitis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Thrombosis
|
1.0%
2/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
|
Vascular disorders
Vena cava thrombosis
|
0.51%
1/197 • Adverse events (AE) were collected from the date of first administration of study treatment until 28 days after the last dose of study treatment up to 5 years
|
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 the 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