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Trial Outcomes & Findings for Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (NCT NCT00399035)

NCT ID: NCT00399035

Last Updated: 2016-12-28

Results Overview

RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1254 participants

Primary outcome timeframe

RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.

Results posted on

2016-12-28

Participant Flow

Randomised=full analysis set: Cediranib 20mg=502, Placebo=358; Safety set: Cediranib 20mg=500, Cediranib 30mg=214, Placebo=358

Cediranib 30 mg discontinued following Phase II, Cediranib 20 mg chosen dose for comparing with Placebo. 1254 patients enrolled to the study, 1076 recieved study treatment; 2 patients lost for Cediranib 20 mg/day, and 2 patients lost for Cediranib 30 mg/day.The 4 patients that didn't receive drug are intentionally included.

Participant milestones

Participant milestones
Measure
Cediranib 20 mg/Day
\[Cediranib 20mg/day+FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Cediranib 30 mg/Day
\[Cediranib 30mg/day+FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Placebo
\[Placebo +FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Overall Study
STARTED
502
216
358
Overall Study
COMPLETED
189
58
106
Overall Study
NOT COMPLETED
313
158
252

Reasons for withdrawal

Reasons for withdrawal
Measure
Cediranib 20 mg/Day
\[Cediranib 20mg/day+FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Cediranib 30 mg/Day
\[Cediranib 30mg/day+FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Placebo
\[Placebo +FOLFOX/XELOX\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
Overall Study
Death
289
141
234
Overall Study
Lost to Follow-up
2
1
5
Overall Study
Withdrawal by Subject
19
15
12
Overall Study
Incorrect enrolment/eligib not fulfilled
1
0
1
Overall Study
Severe non-compliance with protocol
2
1
0

Baseline Characteristics

Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cediranib 20 mg
n=502 Participants
Cediranib 20 mg + FOLFOX/XELOX
Placebo
n=358 Participants
Placebo + FOLFOX/XELOX
Cediranib 30 mg
n=216 Participants
Cediranib 30 mg/day + FOLFOX/XELOX
Total
n=1076 Participants
Total of all reporting groups
Age, Continuous
57.8 years
STANDARD_DEVIATION 11.14 • n=5 Participants
57.2 years
STANDARD_DEVIATION 11.63 • n=7 Participants
59.4 years
STANDARD_DEVIATION 10.69 • n=5 Participants
57.6 years
STANDARD_DEVIATION 11.34 • n=4 Participants
Gender
Female
203 Participants
n=5 Participants
146 Participants
n=7 Participants
93 Participants
n=5 Participants
442 Participants
n=4 Participants
Gender
Male
299 Participants
n=5 Participants
212 Participants
n=7 Participants
123 Participants
n=5 Participants
634 Participants
n=4 Participants

PRIMARY outcome

Timeframe: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=502 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=358 Participants
Placebo + FOLFOX/XELOX
Progression-free Survival
8.6 Months
Interval 5.5 to 12.1
8.2 Months
Interval 4.1 to 11.1

PRIMARY outcome

Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Number of months from randomisation to the date of death from any cause

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=502 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=358 Participants
Placebo + FOLFOX/XELOX
Overall Survival
19.7 Months
Interval 11.0 to 36.1
18.9 Months
Interval 11.0 to 28.9

SECONDARY outcome

Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=502 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=358 Participants
Placebo + FOLFOX/XELOX
Overall Response Rate
254 Participants
178 Participants

SECONDARY outcome

Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=474 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=339 Participants
Placebo + FOLFOX/XELOX
Best Percentage Change in Tumour Size
-42.49 Percentage [change in tumour size (mm) ]
Standard Deviation 28.139
-40.61 Percentage [change in tumour size (mm) ]
Standard Deviation 31.992

SECONDARY outcome

Timeframe: Treatment period from initial response up until data cut-off date of 21/03/10

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=254 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=178 Participants
Placebo + FOLFOX/XELOX
Duration of Response
8.5 Months
Interval 5.9 to 12.7
6.9 Months
Interval 4.8 to 11.0

SECONDARY outcome

Timeframe: Post-randomisation until end of study

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Number of patients undergoing liver resection, based on patients with liver disease at baseline

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=387 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=271 Participants
Placebo + FOLFOX/XELOX
Rate of Resection of Liver Metastases
21 Participants
17 Participants

SECONDARY outcome

Timeframe: Post-randomisation until end of study

Population: 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. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Number of days from post-randomisation surgery until wound healing complications

Outcome measures

Outcome measures
Measure
Cediranib 20 mg
n=94 Participants
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo
n=79 Participants
Placebo + FOLFOX/XELOX
Time to Wound Healing Complications
18 Days
Interval 1.0 to 93.0
18 Days
Interval 0.0 to 114.0

Adverse Events

Cediranib 30mg

Serious events: 94 serious events
Other events: 209 other events
Deaths: 0 deaths

Cediranib 20mg

Serious events: 204 serious events
Other events: 485 other events
Deaths: 0 deaths

Placebo

Serious events: 105 serious events
Other events: 341 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cediranib 30mg
n=214 participants at risk
Cediranib 30mg/day + Folfox/Xelox
Cediranib 20mg
n=500 participants at risk
Cediranib 20mg/day + Folfox/Xelox
Placebo
n=358 participants at risk
Placebo + Folfox/Xelox
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/214
2.2%
11/500
2.0%
7/358
Blood and lymphatic system disorders
Neutropenia
0.00%
0/214
1.4%
7/500
0.84%
3/358
Blood and lymphatic system disorders
Febrile Neutropenia
1.9%
4/214
0.80%
4/500
0.84%
3/358
Blood and lymphatic system disorders
Anaemia
0.00%
0/214
0.60%
3/500
0.56%
2/358
Blood and lymphatic system disorders
Granulocytopenia
0.47%
1/214
0.20%
1/500
0.56%
2/358
Blood and lymphatic system disorders
Coombs Positive Haemolytic Anaemia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
0.00%
0/214
0.20%
1/500
0.00%
0/358
Blood and lymphatic system disorders
Leukopenia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Blood and lymphatic system disorders
Pancytopenia
0.47%
1/214
0.00%
0/500
0.00%
0/358
Cardiac disorders
Atrial Fibrillation
1.4%
3/214
0.40%
2/500
0.84%
3/358
Cardiac disorders
Myocardial Infarction
1.4%
3/214
0.20%
1/500
0.00%
0/358
Cardiac disorders
Cardiac Failure
0.93%
2/214
0.00%
0/500
0.00%
0/358
Cardiac disorders
Myocardial Ischaemia
0.00%
0/214
0.40%
2/500
0.28%
1/358
Cardiac disorders
Acute Left Ventricular Failure
0.00%
0/214
0.00%
0/500
0.28%
1/358
Cardiac disorders
Angina Pectoris
0.00%
0/214
0.20%
1/500
0.28%
1/358
Cardiac disorders
Bradycardia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Cardiac disorders
Cardiac Arrest
0.00%
0/214
0.20%
1/500
0.00%
0/358
Cardiac disorders
Cardiopulmonary Failure
0.47%
1/214
0.00%
0/500
0.00%
0/358
Cardiac disorders
Coronary Artery Disease
0.00%
0/214
0.20%
1/500
0.00%
0/358
Cardiac disorders
Tachycardia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Cardiac disorders
Ventricular Arrhythmia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Cardiac disorders
Ventricular Dysfunction
0.47%
1/214
0.00%
0/500
0.00%
0/358
Endocrine disorders
Hypothyroidism
0.93%
2/214
0.00%
0/500
0.00%
0/358
Endocrine disorders
Thyroiditis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Eye disorders
Retinal Haemorrhage
0.47%
1/214
0.00%
0/500
0.00%
0/358
Eye disorders
Retinal Vein Occlusion
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Diarrhoea
6.5%
14/214
6.8%
34/500
3.1%
11/358
Gastrointestinal disorders
Intestinal Obstruction
1.4%
3/214
1.6%
8/500
1.1%
4/358
Gastrointestinal disorders
Vomiting
2.3%
5/214
1.4%
7/500
2.2%
8/358
Gastrointestinal disorders
Ileus
0.47%
1/214
1.0%
5/500
1.1%
4/358
Gastrointestinal disorders
Constipation
0.00%
0/214
0.80%
4/500
0.28%
1/358
Gastrointestinal disorders
Gastrointestinal Haemorrhage
1.4%
3/214
0.80%
4/500
0.56%
2/358
Gastrointestinal disorders
Abdominal Pain
1.4%
3/214
0.60%
3/500
0.84%
3/358
Gastrointestinal disorders
Nausea
1.4%
3/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Stomatitis
1.4%
3/214
0.40%
2/500
0.28%
1/358
Gastrointestinal disorders
Subileus
1.4%
3/214
0.40%
2/500
0.56%
2/358
Gastrointestinal disorders
Gastritis
0.00%
0/214
0.40%
2/500
0.00%
0/358
Gastrointestinal disorders
Intestinal Haemorrhage
0.47%
1/214
0.20%
1/500
0.56%
2/358
Gastrointestinal disorders
Rectal Haemorrhage
0.00%
0/214
0.40%
2/500
0.28%
1/358
Gastrointestinal disorders
Abdominal Hernia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Abdominal Pain Upper
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Anal Haemorrhage
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Ascites
0.00%
0/214
0.20%
1/500
0.28%
1/358
Gastrointestinal disorders
Colitis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Colonic Obstruction
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Duodenal Ulcer Perforation
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Dysphagia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Gastrointestinal Fistula
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Gastrointestinal Necrosis
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Gastrointestinal Obstruction
0.47%
1/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Gastrointestinal Perforation
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Haematemesis
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Haematochezia
0.00%
0/214
0.20%
1/500
0.28%
1/358
Gastrointestinal disorders
Haemorrhoids
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Ileitis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Ileus Paralytic
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Inguinal Hernia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Intestinal Fistula
0.00%
0/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Intestinal Perforation
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Large Intestine Perforation
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Mechanical Ileus
0.47%
1/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Melaena
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Mesenteric Vein Thrombosis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Pancreatitis
0.00%
0/214
0.20%
1/500
0.28%
1/358
Gastrointestinal disorders
Peptic Ulcer
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Peritonitis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Proctalgia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Gastrointestinal disorders
Proctocolitis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Rectal Obstruction
0.47%
1/214
0.00%
0/500
0.00%
0/358
Gastrointestinal disorders
Small Intestinal Obstruction
0.47%
1/214
0.00%
0/500
0.28%
1/358
Gastrointestinal disorders
Varices Oesophageal
0.00%
0/214
0.20%
1/500
0.00%
0/358
General disorders
Pyrexia
0.93%
2/214
1.0%
5/500
1.1%
4/358
General disorders
Asthenia
0.47%
1/214
0.20%
1/500
0.84%
3/358
General disorders
Fatigue
0.93%
2/214
0.60%
3/500
0.00%
0/358
General disorders
Death
0.93%
2/214
0.20%
1/500
0.28%
1/358
General disorders
General Physical Health Deterioration
0.47%
1/214
0.20%
1/500
0.00%
0/358
General disorders
Infusion Site Irritation
0.47%
1/214
0.00%
0/500
0.00%
0/358
General disorders
Multi-Organ Failure
0.00%
0/214
0.00%
0/500
0.28%
1/358
General disorders
Performance Status Decreased
0.47%
1/214
0.00%
0/500
0.00%
0/358
General disorders
Sudden Death
0.00%
0/214
0.00%
0/500
0.28%
1/358
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/214
0.20%
1/500
0.84%
3/358
Hepatobiliary disorders
Cholecystitis
0.00%
0/214
0.40%
2/500
0.00%
0/358
Hepatobiliary disorders
Cholecystitis Acute
0.00%
0/214
0.40%
2/500
0.00%
0/358
Hepatobiliary disorders
Bile Duct Obstruction
0.47%
1/214
0.00%
0/500
0.00%
0/358
Hepatobiliary disorders
Cholangitis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Hepatobiliary disorders
Cholestasis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Hepatobiliary disorders
Hepatic Function Abnormal
0.00%
0/214
0.20%
1/500
0.28%
1/358
Hepatobiliary disorders
Hepatorenal Failure
0.00%
0/214
0.00%
0/500
0.28%
1/358
Hepatobiliary disorders
Jaundice
0.00%
0/214
0.00%
0/500
0.28%
1/358
Immune system disorders
Anaphylactic Reaction
0.00%
0/214
0.00%
0/500
0.84%
3/358
Immune system disorders
Drug Hypersensitivity
0.47%
1/214
0.60%
3/500
0.56%
2/358
Immune system disorders
Hypersensitivity
0.47%
1/214
0.40%
2/500
0.00%
0/358
Immune system disorders
Food Allergy
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Pneumonia
1.4%
3/214
1.4%
7/500
2.2%
8/358
Infections and infestations
Urinary Tract Infection
0.00%
0/214
1.2%
6/500
0.56%
2/358
Infections and infestations
Sepsis
1.4%
3/214
0.80%
4/500
0.84%
3/358
Infections and infestations
Gastroenteritis
0.93%
2/214
0.60%
3/500
0.00%
0/358
Infections and infestations
Septic Shock
0.00%
0/214
0.60%
3/500
0.28%
1/358
Infections and infestations
Cellulitis
0.00%
0/214
0.40%
2/500
0.28%
1/358
Infections and infestations
Abdominal Wall Abscess
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Acute Sinusitis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Amoebiasis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Amoebic Dysentery
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Appendicitis Perforated
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Blastocystis Infection
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Bronchitis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Bronchopneumonia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Infections and infestations
Campylobacter Intestinal Infection
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Catheter Related Infection
0.47%
1/214
0.20%
1/500
0.28%
1/358
Infections and infestations
Catheter Sepsis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Catheter Site Infection
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Central Line Infection
0.00%
0/214
0.20%
1/500
0.28%
1/358
Infections and infestations
Colostomy Infection
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Dengue Fever
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Infected Epidermal Cyst
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Lower Respiratory Tract Infection
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Lung Abscess
0.47%
1/214
0.00%
0/500
0.00%
0/358
Infections and infestations
Meningitis Bacterial
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Oral Candidiasis
0.00%
0/214
0.00%
0/500
0.28%
1/358
Infections and infestations
Pyelonephritis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Pyothorax
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Scrotal Abscess
0.00%
0/214
0.00%
0/500
0.28%
1/358
Infections and infestations
Staphylococcal Sepsis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Upper Respiratory Tract Infection
0.00%
0/214
0.00%
0/500
0.28%
1/358
Infections and infestations
Viral Upper Respiratory Tract Infection
0.00%
0/214
0.20%
1/500
0.00%
0/358
Infections and infestations
Wound Infection
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
0.93%
2/214
0.40%
2/500
1.1%
4/358
Injury, poisoning and procedural complications
Comminuted Fracture
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Femur Fracture
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Overdose
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Peroneal Nerve Injury
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Post Procedural Complication
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Postoperative Hernia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Postoperative Wound Complication
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Spinal Fracture
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Stent Occlusion
0.00%
0/214
0.00%
0/500
0.28%
1/358
Injury, poisoning and procedural complications
Subdural Haematoma
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Upper Limb Fracture
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Ureteric Injury
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Wound Complication
0.00%
0/214
0.20%
1/500
0.00%
0/358
Injury, poisoning and procedural complications
Wound Dehiscence
0.47%
1/214
0.00%
0/500
0.00%
0/358
Investigations
Bilirubin Conjugated Increased
0.00%
0/214
0.20%
1/500
0.00%
0/358
Investigations
International Normalised Ratio Increased
0.00%
0/214
0.20%
1/500
0.00%
0/358
Investigations
Liver Function Test Abnormal
0.00%
0/214
0.20%
1/500
0.00%
0/358
Investigations
Platelet Count Decreased
0.47%
1/214
0.00%
0/500
0.28%
1/358
Metabolism and nutrition disorders
Dehydration
3.7%
8/214
2.8%
14/500
2.0%
7/358
Metabolism and nutrition disorders
Decreased Appetite
0.00%
0/214
0.60%
3/500
0.28%
1/358
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/214
0.00%
0/500
0.56%
2/358
Metabolism and nutrition disorders
Diabetes Mellitus
0.00%
0/214
0.20%
1/500
0.00%
0/358
Metabolism and nutrition disorders
Hyperammonaemia
0.47%
1/214
0.00%
0/500
0.00%
0/358
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Metabolism and nutrition disorders
Hypokalaemia
0.47%
1/214
0.20%
1/500
0.28%
1/358
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.00%
0/214
0.40%
2/500
0.00%
0/358
Musculoskeletal and connective tissue disorders
Arthralgia
0.47%
1/214
0.20%
1/500
0.28%
1/358
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/214
0.00%
0/500
0.28%
1/358
Musculoskeletal and connective tissue disorders
Groin Pain
0.00%
0/214
0.20%
1/500
0.00%
0/358
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.47%
1/214
0.00%
0/500
0.28%
1/358
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Musculoskeletal and connective tissue disorders
Pathological Fracture
0.47%
1/214
0.00%
0/500
0.00%
0/358
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
0.47%
1/214
0.00%
0/500
0.00%
0/358
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Spinal Cord
0.00%
0/214
0.20%
1/500
0.00%
0/358
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis Carcinoma
0.00%
0/214
0.20%
1/500
0.00%
0/358
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
0.00%
0/214
0.20%
1/500
0.00%
0/358
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Convulsion
0.47%
1/214
0.80%
4/500
0.00%
0/358
Nervous system disorders
Cerebral Ischaemia
0.47%
1/214
0.60%
3/500
0.00%
0/358
Nervous system disorders
Cerebral Haemorrhage
0.93%
2/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Cerebrovascular Accident
0.47%
1/214
0.20%
1/500
0.56%
2/358
Nervous system disorders
Aphasia
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Central Nervous System Lesion
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Cerebral Infarction
0.47%
1/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Dizziness
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Dysarthria
0.00%
0/214
0.00%
0/500
0.28%
1/358
Nervous system disorders
Encephalopathy
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Grand Mal Convulsion
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Hemiparesis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Ischaemic Stroke
0.47%
1/214
0.00%
0/500
0.28%
1/358
Nervous system disorders
Metabolic Encephalopathy
0.00%
0/214
0.00%
0/500
0.28%
1/358
Nervous system disorders
Monoparesis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Nervous System Disorder
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Neuralgia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Neurological Symptom
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Neuropathy Peripheral
0.47%
1/214
0.00%
0/500
0.00%
0/358
Nervous system disorders
Paraesthesia
0.00%
0/214
0.00%
0/500
0.28%
1/358
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Spinal Cord Compression
0.00%
0/214
0.00%
0/500
0.28%
1/358
Nervous system disorders
Subarachnoid Haemorrhage
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Syncope
0.00%
0/214
0.20%
1/500
0.00%
0/358
Nervous system disorders
Transient Ischaemic Attack
0.00%
0/214
0.20%
1/500
0.28%
1/358
Psychiatric disorders
Confusional State
0.47%
1/214
0.20%
1/500
0.28%
1/358
Psychiatric disorders
Personality Change Due To A General Medical Condition
0.00%
0/214
0.20%
1/500
0.00%
0/358
Psychiatric disorders
Suicide Attempt
0.00%
0/214
0.00%
0/500
0.28%
1/358
Renal and urinary disorders
Renal Failure
2.3%
5/214
0.60%
3/500
0.00%
0/358
Renal and urinary disorders
Proteinuria
0.00%
0/214
0.60%
3/500
0.00%
0/358
Renal and urinary disorders
Renal Impairment
0.00%
0/214
0.60%
3/500
0.28%
1/358
Renal and urinary disorders
Renal Failure Acute
0.93%
2/214
0.40%
2/500
0.28%
1/358
Renal and urinary disorders
Azotaemia
0.00%
0/214
0.20%
1/500
0.00%
0/358
Renal and urinary disorders
Haematuria
0.00%
0/214
0.20%
1/500
0.00%
0/358
Renal and urinary disorders
Nephrotic Syndrome
0.00%
0/214
0.20%
1/500
0.28%
1/358
Renal and urinary disorders
Renal Failure Chronic
0.00%
0/214
0.00%
0/500
0.28%
1/358
Renal and urinary disorders
Ureteric Obstruction
0.00%
0/214
0.20%
1/500
0.00%
0/358
Renal and urinary disorders
Urethral Stenosis
0.00%
0/214
0.00%
0/500
0.28%
1/358
Renal and urinary disorders
Urinary Bladder Haemorrhage
0.00%
0/214
0.20%
1/500
0.00%
0/358
Renal and urinary disorders
Urinary Retention
0.00%
0/214
0.20%
1/500
0.00%
0/358
Reproductive system and breast disorders
Vaginal Haemorrhage
0.00%
0/214
0.60%
3/500
0.00%
0/358
Reproductive system and breast disorders
Female Genital Tract Fistula
0.00%
0/214
0.00%
0/500
0.28%
1/358
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
1.9%
4/214
2.0%
10/500
1.1%
4/358
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.47%
1/214
0.80%
4/500
0.28%
1/358
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/214
0.20%
1/500
0.56%
2/358
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Dysaesthesia Pharynx
0.00%
0/214
0.00%
0/500
0.28%
1/358
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
0.47%
1/214
0.00%
0/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.47%
1/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.47%
1/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Hyperventilation
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Laryngospasm
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.47%
1/214
0.00%
0/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Thrombosis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.47%
1/214
0.20%
1/500
0.00%
0/358
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/214
0.20%
1/500
0.00%
0/358
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/214
0.20%
1/500
0.00%
0/358
Vascular disorders
Hypertension
3.7%
8/214
1.2%
6/500
0.56%
2/358
Vascular disorders
Deep Vein Thrombosis
0.93%
2/214
0.60%
3/500
0.28%
1/358
Vascular disorders
Aortic Thrombosis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Vascular disorders
Femoral Artery Occlusion
0.00%
0/214
0.20%
1/500
0.00%
0/358
Vascular disorders
Hypertensive Crisis
0.47%
1/214
0.20%
1/500
0.00%
0/358
Vascular disorders
Orthostatic Hypotension
0.47%
1/214
0.00%
0/500
0.28%
1/358
Vascular disorders
Peripheral Embolism
0.00%
0/214
0.20%
1/500
0.00%
0/358
Vascular disorders
Peripheral Ischaemia
0.47%
1/214
0.00%
0/500
0.00%
0/358
Vascular disorders
Phlebitis
0.00%
0/214
0.20%
1/500
0.00%
0/358
Vascular disorders
Thrombosis
0.47%
1/214
0.00%
0/500
0.00%
0/358
Vascular disorders
Vena Cava Thrombosis
0.00%
0/214
0.20%
1/500
0.00%
0/358

Other adverse events

Other adverse events
Measure
Cediranib 30mg
n=214 participants at risk
Cediranib 30mg/day + Folfox/Xelox
Cediranib 20mg
n=500 participants at risk
Cediranib 20mg/day + Folfox/Xelox
Placebo
n=358 participants at risk
Placebo + Folfox/Xelox
Blood and lymphatic system disorders
Thrombocytopenia
26.2%
56/214
27.8%
139/500
23.5%
84/358
Blood and lymphatic system disorders
Neutropenia
22.9%
49/214
27.6%
138/500
20.9%
75/358
Blood and lymphatic system disorders
Leukopenia
7.0%
15/214
16.8%
84/500
10.9%
39/358
Blood and lymphatic system disorders
Anaemia
11.2%
24/214
8.0%
40/500
12.0%
43/358
Blood and lymphatic system disorders
Granulocytopenia
1.4%
3/214
5.6%
28/500
2.5%
9/358
Endocrine disorders
Hypothyroidism
13.1%
28/214
8.4%
42/500
2.2%
8/358
Gastrointestinal disorders
Diarrhoea
68.7%
147/214
69.2%
346/500
46.1%
165/358
Gastrointestinal disorders
Nausea
43.0%
92/214
51.2%
256/500
47.2%
169/358
Gastrointestinal disorders
Vomiting
38.8%
83/214
46.0%
230/500
35.2%
126/358
Gastrointestinal disorders
Abdominal Pain
15.0%
32/214
26.8%
134/500
21.8%
78/358
Gastrointestinal disorders
Stomatitis
27.6%
59/214
23.6%
118/500
13.4%
48/358
Gastrointestinal disorders
Constipation
15.9%
34/214
17.0%
85/500
21.8%
78/358
Gastrointestinal disorders
Abdominal Pain Upper
11.2%
24/214
11.6%
58/500
7.8%
28/358
Gastrointestinal disorders
Dyspepsia
8.4%
18/214
7.0%
35/500
5.6%
20/358
Gastrointestinal disorders
Abdominal Distension
2.8%
6/214
5.4%
27/500
5.3%
19/358
Gastrointestinal disorders
Flatulence
1.9%
4/214
5.4%
27/500
3.4%
12/358
General disorders
Fatigue
37.4%
80/214
40.0%
200/500
29.1%
104/358
General disorders
Pyrexia
14.5%
31/214
15.2%
76/500
16.8%
60/358
General disorders
Asthenia
15.0%
32/214
14.8%
74/500
12.6%
45/358
General disorders
Oedema Peripheral
10.3%
22/214
10.6%
53/500
12.8%
46/358
Immune system disorders
Drug Hypersensitivity
2.8%
6/214
4.8%
24/500
5.3%
19/358
Infections and infestations
Urinary Tract Infection
7.0%
15/214
8.0%
40/500
3.9%
14/358
Investigations
Weight Decreased
13.1%
28/214
12.6%
63/500
5.0%
18/358
Investigations
Alanine Aminotransferase Increased
5.1%
11/214
6.6%
33/500
4.2%
15/358
Investigations
Aspartate Aminotransferase Increased
4.2%
9/214
6.6%
33/500
5.0%
18/358
Investigations
Platelet Count Decreased
2.8%
6/214
6.6%
33/500
4.7%
17/358
Metabolism and nutrition disorders
Decreased Appetite
43.0%
92/214
45.8%
229/500
34.9%
125/358
Metabolism and nutrition disorders
Hypokalaemia
8.9%
19/214
11.6%
58/500
6.1%
22/358
Musculoskeletal and connective tissue disorders
Pain In Extremity
6.5%
14/214
9.6%
48/500
3.9%
14/358
Musculoskeletal and connective tissue disorders
Back Pain
7.9%
17/214
8.2%
41/500
5.3%
19/358
Musculoskeletal and connective tissue disorders
Arthralgia
7.0%
15/214
6.8%
34/500
3.9%
14/358
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
6.1%
13/214
4.4%
22/500
3.4%
12/358
Nervous system disorders
Peripheral Sensory Neuropathy
21.0%
45/214
28.2%
141/500
24.9%
89/358
Nervous system disorders
Paraesthesia
22.9%
49/214
19.4%
97/500
23.7%
85/358
Nervous system disorders
Neuropathy Peripheral
11.2%
24/214
15.4%
77/500
17.9%
64/358
Nervous system disorders
Headache
16.4%
35/214
14.0%
70/500
9.5%
34/358
Nervous system disorders
Dizziness
8.9%
19/214
10.4%
52/500
6.4%
23/358
Nervous system disorders
Hypoaesthesia
3.3%
7/214
7.6%
38/500
4.7%
17/358
Nervous system disorders
Dysgeusia
6.5%
14/214
5.2%
26/500
7.0%
25/358
Nervous system disorders
Dysaesthesia
6.1%
13/214
3.2%
16/500
3.1%
11/358
Psychiatric disorders
Insomnia
7.0%
15/214
10.0%
50/500
7.5%
27/358
Renal and urinary disorders
Proteinuria
9.3%
20/214
12.0%
60/500
3.4%
12/358
Respiratory, thoracic and mediastinal disorders
Dysphonia
18.2%
39/214
13.4%
67/500
1.1%
4/358
Respiratory, thoracic and mediastinal disorders
Epistaxis
17.3%
37/214
12.6%
63/500
8.7%
31/358
Respiratory, thoracic and mediastinal disorders
Cough
11.2%
24/214
10.0%
50/500
9.8%
35/358
Respiratory, thoracic and mediastinal disorders
Dyspnoea
6.5%
14/214
5.8%
29/500
6.7%
24/358
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
5.6%
12/214
5.6%
28/500
1.7%
6/358
Respiratory, thoracic and mediastinal disorders
Hiccups
5.1%
11/214
4.6%
23/500
2.2%
8/358
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
24.8%
53/214
24.6%
123/500
15.9%
57/358
Skin and subcutaneous tissue disorders
Alopecia
8.4%
18/214
7.6%
38/500
6.1%
22/358
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
4.2%
9/214
6.8%
34/500
7.0%
25/358
Skin and subcutaneous tissue disorders
Rash
4.2%
9/214
6.6%
33/500
5.3%
19/358
Skin and subcutaneous tissue disorders
Dry Skin
6.5%
14/214
3.2%
16/500
3.1%
11/358
Vascular disorders
Hypertension
44.9%
96/214
45.2%
226/500
11.5%
41/358
Vascular disorders
Phlebitis
3.3%
7/214
3.8%
19/500
5.0%
18/358

Additional Information

Gerard Lynch

AstraZeneca

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