Trial Outcomes & Findings for First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (NCT NCT00384176)
NCT ID: NCT00384176
Last Updated: 2017-04-14
Results Overview
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1814 participants
Primary outcome timeframe
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Results posted on
2017-04-14
Participant Flow
Enrolled = 1814 though not all patient randomised. Randomised= Intent to treat (ITT): Cediranib 20mg 709, Cediranib 30mg 192 Bevacizumab 713; Safety: Cediranib 20mg 705, Cediranib 30mg 191 Bevacizumab 704
Cediranib 30mg discontinued following Phase II, Cediranib 20mg chosen dose for comparing with Bevacizumab. 200 patients dropped prior to treatment. Study was set up as a phase II/III study. Participants were enrolled into both phases if they participated in both Phase II/III, but are only counted once in the Enrollment Number and in the Results.
Participant milestones
| Measure |
Cediranib 20 mg
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
709
|
713
|
192
|
|
Overall Study
COMPLETED
|
397
|
394
|
60
|
|
Overall Study
NOT COMPLETED
|
312
|
319
|
132
|
Reasons for withdrawal
| Measure |
Cediranib 20 mg
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Overall Study
Death
|
239
|
247
|
105
|
|
Overall Study
Withdrawal by Subject
|
52
|
48
|
22
|
|
Overall Study
Lost to Follow-up
|
16
|
18
|
4
|
|
Overall Study
Incorrect enrol/elig crit not fulfilled
|
2
|
3
|
0
|
|
Overall Study
Longer QTC as Visit 1
|
1
|
0
|
0
|
|
Overall Study
Toxicity of treatment
|
1
|
0
|
0
|
|
Overall Study
Did not receive study treatment
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Liver metastases, colon resec. planned
|
1
|
0
|
0
|
Baseline Characteristics
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Baseline characteristics by cohort
| Measure |
Cediranib 20 mg
n=709 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=713 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
n=192 Participants
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Total
n=1614 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
297 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
669 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
412 Participants
n=5 Participants
|
414 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
945 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progressionPopulation: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Outcome measures
| Measure |
Cediranib 20 mg
n=709 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=713 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Progression Free Survival
|
9.9 Months
Interval 6.3 to 13.5
|
10.3 Months
Interval 6.5 to 14.1
|
—
|
SECONDARY outcome
Timeframe: Randomisation until data cut-offPopulation: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.
Number of months from randomisation to the date of death from any cause
Outcome measures
| Measure |
Cediranib 20 mg
n=709 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=713 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Overall Survival
|
22.8 Months
Interval 13.3 to 32.3
|
21.3 Months
Interval 12.2 to 32.8
|
—
|
SECONDARY outcome
Timeframe: Up until data cut-offPopulation: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.
Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below: CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Outcome measures
| Measure |
Cediranib 20 mg
n=709 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=713 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Objective Response Rate
|
328 Participants
|
337 Participants
|
—
|
SECONDARY outcome
Timeframe: Up until data cut-off date of 15/11/2007Population: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.
Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
Outcome measures
| Measure |
Cediranib 20 mg
n=328 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=337 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Duration of Response
|
8.6 Months
Interval 6.1 to 12.1
|
9.6 Months
Interval 6.5 to 13.6
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
Outcome measures
| Measure |
Cediranib 20 mg
n=634 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=649 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Percentage Change in Tumour Size
|
-23.2 Percentage change in tumour size
Standard Deviation 21.8
|
-22.1 Percentage change in tumour size
Standard Deviation 19.55
|
—
|
SECONDARY outcome
Timeframe: Baseline through to data cut-offTime to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.
Outcome measures
| Measure |
Cediranib 20 mg
n=709 Participants
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Bevacizumab 5 mg/kg
n=713 Participants
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
\+ FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
|---|---|---|---|
|
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
|
170 Days
Interval 56.0 to 328.0
|
245 Days
Interval 112.0 to 348.0
|
—
|
Adverse Events
Cediranib 20 mg
Serious events: 275 serious events
Other events: 684 other events
Deaths: 0 deaths
Cediranib 30 mg
Serious events: 90 serious events
Other events: 187 other events
Deaths: 0 deaths
1Bevacizumab 5mg/kg
Serious events: 231 serious events
Other events: 672 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cediranib 20 mg
n=705 participants at risk
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
n=191 participants at risk
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
1Bevacizumab 5mg/kg
n=704 participants at risk
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.6%
11/705
|
0.52%
1/191
|
1.8%
13/704
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
8/705
|
2.6%
5/191
|
1.6%
11/704
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.85%
6/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic Purpura
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.14%
1/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Cardiac disorders
Cardiac Failure
|
0.43%
3/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.43%
3/705
|
0.52%
1/191
|
0.28%
2/704
|
|
Cardiac disorders
Atrial Fibrillation
|
0.14%
1/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Cardiac disorders
Myocardial Infarction
|
0.28%
2/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Angina Unstable
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Atrial Thrombosis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Bradycardia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Cardiac disorders
Pericarditis Constrictive
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Congenital, familial and genetic disorders
Dihydropyrimidine Dehydrogenase Deficiency
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Ear and labyrinth disorders
Deafness
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Eye disorders
Diplopia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
30/705
|
5.8%
11/191
|
1.8%
13/704
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.3%
9/705
|
1.0%
2/191
|
1.7%
12/704
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
11/705
|
1.6%
3/191
|
1.7%
12/704
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
9/705
|
1.0%
2/191
|
1.4%
10/704
|
|
Gastrointestinal disorders
Nausea
|
1.4%
10/705
|
0.52%
1/191
|
0.57%
4/704
|
|
Gastrointestinal disorders
Ileus
|
0.99%
7/705
|
1.0%
2/191
|
0.85%
6/704
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.99%
7/705
|
0.00%
0/191
|
0.99%
7/704
|
|
Gastrointestinal disorders
Stomatitis
|
0.99%
7/705
|
1.0%
2/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/705
|
0.52%
1/191
|
0.85%
6/704
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.71%
5/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/705
|
0.00%
0/191
|
0.57%
4/704
|
|
Gastrointestinal disorders
Constipation
|
0.43%
3/705
|
0.52%
1/191
|
0.57%
4/704
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.28%
2/705
|
1.0%
2/191
|
0.43%
3/704
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Gastrointestinal disorders
Subileus
|
0.43%
3/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Duodenitis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Gastrointestinal Toxicity
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.14%
1/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.14%
1/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Melaena
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Periproctitis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Peritonitis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Rectal Perforation
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Pyrexia
|
3.0%
21/705
|
4.7%
9/191
|
1.6%
11/704
|
|
General disorders
Fatigue
|
0.85%
6/705
|
3.7%
7/191
|
0.00%
0/704
|
|
General disorders
Asthenia
|
0.43%
3/705
|
1.0%
2/191
|
0.14%
1/704
|
|
General disorders
Malaise
|
0.43%
3/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Non-Cardiac Chest Pain
|
0.43%
3/705
|
1.0%
2/191
|
0.14%
1/704
|
|
General disorders
Catheter Related Complication
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Catheter Thrombosis
|
0.28%
2/705
|
0.00%
0/191
|
0.14%
1/704
|
|
General disorders
Chills
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Multi-Organ Failure
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Death
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
General disorders
General Physical Health Deterioration
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
General disorders
Infusion Site Extravasation
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Infusion Site Inflammation
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
General disorders
Mucosal Inflammation
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Oedema
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
General disorders
Oedema Peripheral
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
General disorders
Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
General disorders
Sudden Death
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.28%
2/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.28%
2/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Immune system disorders
Drug Hypersensitivity
|
0.28%
2/705
|
0.52%
1/191
|
0.71%
5/704
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Immune system disorders
Food Allergy
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Pneumonia
|
1.4%
10/705
|
1.0%
2/191
|
0.71%
5/704
|
|
Infections and infestations
Catheter Related Infection
|
0.85%
6/705
|
0.52%
1/191
|
0.85%
6/704
|
|
Infections and infestations
Sepsis
|
0.85%
6/705
|
0.52%
1/191
|
0.85%
6/704
|
|
Infections and infestations
Urinary Tract Infection
|
0.85%
6/705
|
0.52%
1/191
|
0.43%
3/704
|
|
Infections and infestations
Central Line Infection
|
0.57%
4/705
|
0.00%
0/191
|
0.57%
4/704
|
|
Infections and infestations
Infection
|
0.57%
4/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Catheter Sepsis
|
0.14%
1/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Infections and infestations
Abscess
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Anal Abscess
|
0.28%
2/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Gastroenteritis
|
0.28%
2/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Septic Shock
|
0.14%
1/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Sinusitis
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Staphylococcal Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Appendicitis
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Breast Abscess
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Bronchitis
|
0.14%
1/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Infections and infestations
Bronchopneumonia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Catheter Site Cellulitis
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Cellulitis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Cystitis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Endocarditis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Enterococcal Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Gas Gangrene
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Gingival Infection
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Hepatitis C
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Herpes Virus Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Influenza
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Infusion Site Infection
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Lobar Pneumonia
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Lung Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Pelvic Abscess
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Retroperitoneal Abscess
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Urosepsis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Infections and infestations
Viral Diarrhoea
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Viral Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Infections and infestations
Wound Infection
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.43%
3/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Cardiac Valve Replacement Complication
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Investigations
Alanine Aminotransferase Increased
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Blood Pressure Increased
|
0.28%
2/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Body Temperature Increased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Haemoglobin Decreased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Lipase Increased
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Investigations
Transaminases Increased
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Investigations
Viral Test Positive
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Investigations
Weight Decreased
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Dehydration
|
0.85%
6/705
|
2.6%
5/191
|
1.1%
8/704
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.57%
4/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.28%
2/705
|
1.0%
2/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Fluid Intake Reduced
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.28%
2/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.43%
3/705
|
1.0%
2/191
|
0.14%
1/704
|
|
Nervous system disorders
Syncope
|
0.43%
3/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.43%
3/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Nervous system disorders
Convulsion
|
0.00%
0/705
|
1.0%
2/191
|
0.00%
0/704
|
|
Nervous system disorders
Aphasia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Cerebral Infarction
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.14%
1/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Dizziness
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Facial Palsy
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Haemorrhagic Cerebral Infarction
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Nervous system disorders
Headache
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Lethargy
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Nervous system disorders
Loss Of Consciousness
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Nerve Root Lesion
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Nervous system disorders
Somnolence
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Psychiatric disorders
Depression
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Psychiatric disorders
Dissociative Disorder
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Renal and urinary disorders
Renal Failure
|
0.28%
2/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Renal and urinary disorders
Haematuria
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Renal and urinary disorders
Renal Colic
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Renal and urinary disorders
Renal Pain
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Renal and urinary disorders
Urinary Retention
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.8%
13/705
|
3.1%
6/191
|
3.0%
21/704
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
3/705
|
1.0%
2/191
|
0.57%
4/704
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/705
|
0.00%
0/191
|
0.43%
3/704
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.28%
2/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.00%
0/705
|
1.0%
2/191
|
0.00%
0/704
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.3%
9/705
|
1.0%
2/191
|
1.3%
9/704
|
|
Vascular disorders
Hypertension
|
1.3%
9/705
|
2.1%
4/191
|
0.28%
2/704
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.43%
3/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Vascular disorders
Hypertensive Crisis
|
0.28%
2/705
|
1.0%
2/191
|
0.00%
0/704
|
|
Vascular disorders
Hypotension
|
0.14%
1/705
|
0.00%
0/191
|
0.28%
2/704
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.00%
0/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Vascular disorders
Circulatory Collapse
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Vascular disorders
Embolism Venous
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Vascular disorders
Haematoma
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Vascular disorders
Orthostatic Hypotension
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Vascular disorders
Shock Haemorrhagic
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.14%
1/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Vascular disorders
Thrombosis
|
0.00%
0/705
|
0.52%
1/191
|
0.00%
0/704
|
|
Vascular disorders
Vasospasm
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.14%
1/705
|
0.52%
1/191
|
0.14%
1/704
|
|
Vascular disorders
Venous Thrombosis
|
0.14%
1/705
|
0.00%
0/191
|
0.14%
1/704
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.14%
1/705
|
0.00%
0/191
|
0.00%
0/704
|
Other adverse events
| Measure |
Cediranib 20 mg
n=705 participants at risk
Cediranib 20 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
Cediranib 30 mg
n=191 participants at risk
Cediranib 30 mg/day + FOLFOX
The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:
* Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1
* 5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours.
|
1Bevacizumab 5mg/kg
n=704 participants at risk
Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
42.8%
302/705
|
44.5%
85/191
|
32.4%
228/704
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.4%
186/705
|
28.8%
55/191
|
12.1%
85/704
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
50/705
|
8.4%
16/191
|
11.2%
79/704
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.9%
56/705
|
10.5%
20/191
|
7.4%
52/704
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
35/705
|
12.6%
24/191
|
1.1%
8/704
|
|
Gastrointestinal disorders
Diarrhoea
|
68.9%
486/705
|
77.0%
147/191
|
50.3%
354/704
|
|
Gastrointestinal disorders
Nausea
|
50.4%
355/705
|
52.4%
100/191
|
49.6%
349/704
|
|
Gastrointestinal disorders
Stomatitis
|
35.7%
252/705
|
40.3%
77/191
|
26.6%
187/704
|
|
Gastrointestinal disorders
Vomiting
|
31.3%
221/705
|
33.5%
64/191
|
27.3%
192/704
|
|
Gastrointestinal disorders
Constipation
|
20.6%
145/705
|
17.8%
34/191
|
26.6%
187/704
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.8%
161/705
|
25.7%
49/191
|
17.6%
124/704
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
11.6%
82/705
|
11.0%
21/191
|
8.4%
59/704
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
45/705
|
5.8%
11/191
|
8.0%
56/704
|
|
Gastrointestinal disorders
Dry Mouth
|
4.7%
33/705
|
5.2%
10/191
|
4.3%
30/704
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
22/705
|
5.8%
11/191
|
1.4%
10/704
|
|
General disorders
Fatigue
|
44.5%
314/705
|
46.6%
89/191
|
42.5%
299/704
|
|
General disorders
Pyrexia
|
13.0%
92/705
|
13.6%
26/191
|
17.5%
123/704
|
|
General disorders
Asthenia
|
13.6%
96/705
|
16.2%
31/191
|
10.4%
73/704
|
|
General disorders
Oedema Peripheral
|
4.0%
28/705
|
7.3%
14/191
|
5.5%
39/704
|
|
Immune system disorders
Drug Hypersensitivity
|
5.8%
41/705
|
5.2%
10/191
|
7.1%
50/704
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
42/705
|
11.0%
21/191
|
7.1%
50/704
|
|
Infections and infestations
Urinary Tract Infection
|
6.0%
42/705
|
7.9%
15/191
|
6.1%
43/704
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
18/705
|
2.1%
4/191
|
5.1%
36/704
|
|
Investigations
Weight Decreased
|
11.3%
80/705
|
16.8%
32/191
|
8.0%
56/704
|
|
Investigations
Alanine Aminotransferase Increased
|
2.6%
18/705
|
5.8%
11/191
|
1.8%
13/704
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
25.1%
177/705
|
37.2%
71/191
|
22.7%
160/704
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.4%
59/705
|
8.4%
16/191
|
5.4%
38/704
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
54/705
|
10.5%
20/191
|
8.9%
63/704
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.5%
46/705
|
8.4%
16/191
|
5.4%
38/704
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
34/705
|
7.9%
15/191
|
5.7%
40/704
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.7%
40/705
|
3.7%
7/191
|
5.0%
35/704
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
18/705
|
5.8%
11/191
|
3.1%
22/704
|
|
Nervous system disorders
Neuropathy Peripheral
|
30.9%
218/705
|
25.7%
49/191
|
30.1%
212/704
|
|
Nervous system disorders
Paraesthesia
|
22.3%
157/705
|
24.1%
46/191
|
22.4%
158/704
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
19.1%
135/705
|
19.4%
37/191
|
20.5%
144/704
|
|
Nervous system disorders
Headache
|
16.6%
117/705
|
24.1%
46/191
|
12.8%
90/704
|
|
Nervous system disorders
Dysgeusia
|
11.6%
82/705
|
12.6%
24/191
|
11.9%
84/704
|
|
Nervous system disorders
Dizziness
|
7.2%
51/705
|
8.4%
16/191
|
4.7%
33/704
|
|
Nervous system disorders
Lethargy
|
5.7%
40/705
|
6.3%
12/191
|
4.3%
30/704
|
|
Psychiatric disorders
Insomnia
|
7.0%
49/705
|
8.4%
16/191
|
7.8%
55/704
|
|
Psychiatric disorders
Depression
|
3.3%
23/705
|
5.8%
11/191
|
3.3%
23/704
|
|
Renal and urinary disorders
Proteinuria
|
6.8%
48/705
|
12.0%
23/191
|
5.7%
40/704
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.0%
169/705
|
23.6%
45/191
|
24.4%
172/704
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
17.6%
124/705
|
24.6%
47/191
|
11.5%
81/704
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
71/705
|
11.5%
22/191
|
9.7%
68/704
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
60/705
|
14.1%
27/191
|
6.1%
43/704
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.2%
44/705
|
6.8%
13/191
|
5.3%
37/704
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
14.8%
104/705
|
16.2%
31/191
|
9.7%
68/704
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.2%
65/705
|
9.4%
18/191
|
9.1%
64/704
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
51/705
|
7.3%
14/191
|
5.4%
38/704
|
|
Vascular disorders
Hypertension
|
41.4%
292/705
|
48.2%
92/191
|
26.0%
183/704
|
|
Vascular disorders
Phlebitis
|
3.1%
22/705
|
5.2%
10/191
|
4.4%
31/704
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
- Publication restrictions are in place
Restriction type: OTHER