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Trial record 21 of 533 for:    Argentina | Bulgaria

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

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ClinicalTrials.gov Identifier: NCT00399035
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : October 30, 2012
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Cediranib
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Drug: XELOX (Capecitabine and Oxaliplatin)
Drug: Cediranib Placebo
Enrollment 1254
Recruitment Details Randomised=full analysis set: Cediranib 20mg=502, Placebo=358; Safety set: Cediranib 20mg=500, Cediranib 30mg=214, Placebo=358
Pre-assignment Details

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.

Arm/Group Title Cediranib 20 mg/Day Cediranib 30 mg/Day Placebo
Hide Arm/Group Description [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 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 +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.
Period Title: Overall Study
Started 502 216 358
Completed 189 58 106
Not Completed 313 158 252
Reason Not Completed
Death             289             141             234
Lost to Follow-up             2             1             5
Withdrawal by Subject             19             15             12
Incorrect enrolment/eligib not fulfilled             1             0             1
Severe non-compliance with protocol             2             1             0
Arm/Group Title Cediranib 20 mg Placebo Cediranib 30 mg Total
Hide Arm/Group Description Cediranib 20 mg + FOLFOX/XELOX Placebo + FOLFOX/XELOX Cediranib 30 mg/day + FOLFOX/XELOX Total of all reporting groups
Overall Number of Baseline Participants 502 358 216 1076
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 502 participants 358 participants 216 participants 1076 participants
57.8  (11.14) 57.2  (11.63) 59.4  (10.69) 57.6  (11.34)
[1]
Measure Description: Age at informed consent
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 502 participants 358 participants 216 participants 1076 participants
Female
203
  40.4%
146
  40.8%
93
  43.1%
442
  41.1%
Male
299
  59.6%
212
  59.2%
123
  56.9%
634
  58.9%
[1]
Measure Description: Gender at informed consent
1.Primary Outcome
Title Progression-free Survival
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 502 358
Median (Inter-Quartile Range)
Unit of Measure: Months
8.6
(5.5 to 12.1)
8.2
(4.1 to 11.1)
2.Primary Outcome
Title Overall Survival
Hide Description Number of months from randomisation to the date of death from any cause
Time Frame Baseline through to date of death upto and including data cut off date of 21/03/10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 502 358
Median (Inter-Quartile Range)
Unit of Measure: Months
19.7
(11.0 to 36.1)
18.9
(11.0 to 28.9)
3.Secondary Outcome
Title Overall Response Rate
Hide Description 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
Time Frame Baseline through to date of death upto and including data cut off date of 21/03/10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 502 358
Measure Type: Number
Unit of Measure: Participants
254 178
4.Secondary Outcome
Title Best Percentage Change in Tumour Size
Hide Description Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
Time Frame Baseline through to date of death upto and including data cut off date of 21/03/10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 474 339
Mean (Standard Deviation)
Unit of Measure: Percentage [change in tumour size (mm) ]
-42.49  (28.139) -40.61  (31.992)
5.Secondary Outcome
Title Duration of Response
Hide Description 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.
Time Frame Treatment period from initial response up until data cut-off date of 21/03/10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 254 178
Median (Inter-Quartile Range)
Unit of Measure: Months
8.5
(5.9 to 12.7)
6.9
(4.8 to 11.0)
6.Secondary Outcome
Title Rate of Resection of Liver Metastases
Hide Description Number of patients undergoing liver resection, based on patients with liver disease at baseline
Time Frame Post-randomisation until end of study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 387 271
Measure Type: Number
Unit of Measure: Participants
21 17
7.Secondary Outcome
Title Time to Wound Healing Complications
Hide Description Number of days from post-randomisation surgery until wound healing complications
Time Frame Post-randomisation until end of study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cediranib 20 mg Placebo
Hide Arm/Group Description:
Cediranib 20 mg/day + FOLFOX/XELOX
Placebo + FOLFOX/XELOX
Overall Number of Participants Analyzed 94 79
Median (Full Range)
Unit of Measure: Days
18
(1 to 93)
18
(0 to 114)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cediranib 30mg Cediranib 20mg Placebo
Hide Arm/Group Description Cediranib 30mg/day + Folfox/Xelox Cediranib 20mg/day + Folfox/Xelox Placebo + Folfox/Xelox
All-Cause Mortality
Cediranib 30mg Cediranib 20mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cediranib 30mg Cediranib 20mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   94/214 (43.93%)   204/500 (40.80%)   105/358 (29.33%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  0/214 (0.00%)  11/500 (2.20%)  7/358 (1.96%) 
Neutropenia  1  0/214 (0.00%)  7/500 (1.40%)  3/358 (0.84%) 
Febrile Neutropenia  1  4/214 (1.87%)  4/500 (0.80%)  3/358 (0.84%) 
Anaemia  1  0/214 (0.00%)  3/500 (0.60%)  2/358 (0.56%) 
Granulocytopenia  1  1/214 (0.47%)  1/500 (0.20%)  2/358 (0.56%) 
Coombs Positive Haemolytic Anaemia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Disseminated Intravascular Coagulation  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Leukopenia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Lymphopenia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Pancytopenia  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Cardiac disorders       
Atrial Fibrillation  1  3/214 (1.40%)  2/500 (0.40%)  3/358 (0.84%) 
Myocardial Infarction  1  3/214 (1.40%)  1/500 (0.20%)  0/358 (0.00%) 
Cardiac Failure  1  2/214 (0.93%)  0/500 (0.00%)  0/358 (0.00%) 
Myocardial Ischaemia  1  0/214 (0.00%)  2/500 (0.40%)  1/358 (0.28%) 
Acute Left Ventricular Failure  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Angina Pectoris  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Bradycardia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Cardiac Arrest  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Cardiopulmonary Failure  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Coronary Artery Disease  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Tachycardia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Ventricular Arrhythmia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Ventricular Dysfunction  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  2/214 (0.93%)  0/500 (0.00%)  0/358 (0.00%) 
Thyroiditis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Eye disorders       
Retinal Haemorrhage  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Retinal Vein Occlusion  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  14/214 (6.54%)  34/500 (6.80%)  11/358 (3.07%) 
Intestinal Obstruction  1  3/214 (1.40%)  8/500 (1.60%)  4/358 (1.12%) 
Vomiting  1  5/214 (2.34%)  7/500 (1.40%)  8/358 (2.23%) 
Ileus  1  1/214 (0.47%)  5/500 (1.00%)  4/358 (1.12%) 
Constipation  1  0/214 (0.00%)  4/500 (0.80%)  1/358 (0.28%) 
Gastrointestinal Haemorrhage  1  3/214 (1.40%)  4/500 (0.80%)  2/358 (0.56%) 
Abdominal Pain  1  3/214 (1.40%)  3/500 (0.60%)  3/358 (0.84%) 
Nausea  1  3/214 (1.40%)  1/500 (0.20%)  0/358 (0.00%) 
Stomatitis  1  3/214 (1.40%)  2/500 (0.40%)  1/358 (0.28%) 
Subileus  1  3/214 (1.40%)  2/500 (0.40%)  2/358 (0.56%) 
Gastritis  1  0/214 (0.00%)  2/500 (0.40%)  0/358 (0.00%) 
Intestinal Haemorrhage  1  1/214 (0.47%)  1/500 (0.20%)  2/358 (0.56%) 
Rectal Haemorrhage  1  0/214 (0.00%)  2/500 (0.40%)  1/358 (0.28%) 
Abdominal Hernia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Abdominal Pain Upper  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Anal Haemorrhage  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Ascites  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Colitis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Colonic Obstruction  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Duodenal Ulcer Perforation  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Dysphagia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Gastrointestinal Fistula  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Gastrointestinal Necrosis  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Gastrointestinal Obstruction  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Gastrointestinal Perforation  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Haematemesis  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Haematochezia  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Haemorrhoids  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Ileitis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Ileus Paralytic  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Inguinal Hernia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Intestinal Fistula  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Intestinal Perforation  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Large Intestine Perforation  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Lower Gastrointestinal Haemorrhage  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Mechanical Ileus  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Melaena  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Mesenteric Vein Thrombosis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Pancreatitis  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Peptic Ulcer  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Peritonitis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Proctalgia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Proctocolitis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Rectal Obstruction  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Small Intestinal Obstruction  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Varices Oesophageal  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
General disorders       
Pyrexia  1  2/214 (0.93%)  5/500 (1.00%)  4/358 (1.12%) 
Asthenia  1  1/214 (0.47%)  1/500 (0.20%)  3/358 (0.84%) 
Fatigue  1  2/214 (0.93%)  3/500 (0.60%)  0/358 (0.00%) 
Death  1  2/214 (0.93%)  1/500 (0.20%)  1/358 (0.28%) 
General Physical Health Deterioration  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Infusion Site Irritation  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Multi-Organ Failure  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Performance Status Decreased  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Sudden Death  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/214 (0.00%)  1/500 (0.20%)  3/358 (0.84%) 
Cholecystitis  1  0/214 (0.00%)  2/500 (0.40%)  0/358 (0.00%) 
Cholecystitis Acute  1  0/214 (0.00%)  2/500 (0.40%)  0/358 (0.00%) 
Bile Duct Obstruction  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Cholangitis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Cholestasis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Hepatic Function Abnormal  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Hepatorenal Failure  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Jaundice  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Immune system disorders       
Anaphylactic Reaction  1  0/214 (0.00%)  0/500 (0.00%)  3/358 (0.84%) 
Drug Hypersensitivity  1  1/214 (0.47%)  3/500 (0.60%)  2/358 (0.56%) 
Hypersensitivity  1  1/214 (0.47%)  2/500 (0.40%)  0/358 (0.00%) 
Food Allergy  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Infections and infestations       
Pneumonia  1  3/214 (1.40%)  7/500 (1.40%)  8/358 (2.23%) 
Urinary Tract Infection  1  0/214 (0.00%)  6/500 (1.20%)  2/358 (0.56%) 
Sepsis  1  3/214 (1.40%)  4/500 (0.80%)  3/358 (0.84%) 
Gastroenteritis  1  2/214 (0.93%)  3/500 (0.60%)  0/358 (0.00%) 
Septic Shock  1  0/214 (0.00%)  3/500 (0.60%)  1/358 (0.28%) 
Cellulitis  1  0/214 (0.00%)  2/500 (0.40%)  1/358 (0.28%) 
Abdominal Wall Abscess  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Acute Sinusitis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Amoebiasis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Amoebic Dysentery  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Appendicitis Perforated  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Blastocystis Infection  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Bronchitis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Bronchopneumonia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Campylobacter Intestinal Infection  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Catheter Related Infection  1  1/214 (0.47%)  1/500 (0.20%)  1/358 (0.28%) 
Catheter Sepsis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Catheter Site Infection  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Central Line Infection  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Colostomy Infection  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Dengue Fever  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Infected Epidermal Cyst  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Lower Respiratory Tract Infection  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Lung Abscess  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Meningitis Bacterial  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Oral Candidiasis  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Pyelonephritis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Pyothorax  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Scrotal Abscess  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Staphylococcal Sepsis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Upper Respiratory Tract Infection  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Viral Upper Respiratory Tract Infection  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Wound Infection  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Injury, poisoning and procedural complications       
Post Procedural Haemorrhage  1  2/214 (0.93%)  2/500 (0.40%)  4/358 (1.12%) 
Comminuted Fracture  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Femur Fracture  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Gastrointestinal Stoma Complication  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Overdose  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Peroneal Nerve Injury  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Post Procedural Complication  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Postoperative Hernia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Postoperative Wound Complication  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Spinal Fracture  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Stent Occlusion  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Subdural Haematoma  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Upper Limb Fracture  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Ureteric Injury  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Wound Complication  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Wound Dehiscence  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Investigations       
Bilirubin Conjugated Increased  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
International Normalised Ratio Increased  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Liver Function Test Abnormal  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Platelet Count Decreased  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Metabolism and nutrition disorders       
Dehydration  1  8/214 (3.74%)  14/500 (2.80%)  7/358 (1.96%) 
Decreased Appetite  1  0/214 (0.00%)  3/500 (0.60%)  1/358 (0.28%) 
Hyponatraemia  1  0/214 (0.00%)  0/500 (0.00%)  2/358 (0.56%) 
Diabetes Mellitus  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Hyperammonaemia  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Hypertriglyceridaemia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Hypokalaemia  1  1/214 (0.47%)  1/500 (0.20%)  1/358 (0.28%) 
Hypoproteinaemia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain In Extremity  1  0/214 (0.00%)  2/500 (0.40%)  0/358 (0.00%) 
Arthralgia  1  1/214 (0.47%)  1/500 (0.20%)  1/358 (0.28%) 
Back Pain  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Groin Pain  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Muscular Weakness  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Osteoarthritis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Pathological Fracture  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal Cell Carcinoma  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Benign Neoplasm Of Spinal Cord  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Penis Carcinoma  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Renal Cancer  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Squamous Cell Carcinoma  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Nervous system disorders       
Convulsion  1  1/214 (0.47%)  4/500 (0.80%)  0/358 (0.00%) 
Cerebral Ischaemia  1  1/214 (0.47%)  3/500 (0.60%)  0/358 (0.00%) 
Cerebral Haemorrhage  1  2/214 (0.93%)  1/500 (0.20%)  0/358 (0.00%) 
Cerebrovascular Accident  1  1/214 (0.47%)  1/500 (0.20%)  2/358 (0.56%) 
Aphasia  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Central Nervous System Lesion  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Cerebral Infarction  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Dizziness  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Dysarthria  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Encephalopathy  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Grand Mal Convulsion  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Hemiparesis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Ischaemic Stroke  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Metabolic Encephalopathy  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Monoparesis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Nervous System Disorder  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Neuralgia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Neurological Symptom  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Neuropathy Peripheral  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Paraesthesia  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Peripheral Sensory Neuropathy  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Reversible Posterior Leukoencephalopathy Syndrome  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Spinal Cord Compression  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Subarachnoid Haemorrhage  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Syncope  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Transient Ischaemic Attack  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Psychiatric disorders       
Confusional State  1  1/214 (0.47%)  1/500 (0.20%)  1/358 (0.28%) 
Personality Change Due To A General Medical Condition  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Suicide Attempt  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Renal and urinary disorders       
Renal Failure  1  5/214 (2.34%)  3/500 (0.60%)  0/358 (0.00%) 
Proteinuria  1  0/214 (0.00%)  3/500 (0.60%)  0/358 (0.00%) 
Renal Impairment  1  0/214 (0.00%)  3/500 (0.60%)  1/358 (0.28%) 
Renal Failure Acute  1  2/214 (0.93%)  2/500 (0.40%)  1/358 (0.28%) 
Azotaemia  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Haematuria  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Nephrotic Syndrome  1  0/214 (0.00%)  1/500 (0.20%)  1/358 (0.28%) 
Renal Failure Chronic  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Ureteric Obstruction  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Urethral Stenosis  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Urinary Bladder Haemorrhage  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Urinary Retention  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Reproductive system and breast disorders       
Vaginal Haemorrhage  1  0/214 (0.00%)  3/500 (0.60%)  0/358 (0.00%) 
Female Genital Tract Fistula  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism  1  4/214 (1.87%)  10/500 (2.00%)  4/358 (1.12%) 
Dyspnoea  1  1/214 (0.47%)  4/500 (0.80%)  1/358 (0.28%) 
Pleural Effusion  1  0/214 (0.00%)  1/500 (0.20%)  2/358 (0.56%) 
Asthma  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Dysaesthesia Pharynx  1  0/214 (0.00%)  0/500 (0.00%)  1/358 (0.28%) 
Dyspnoea Exertional  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Epistaxis  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Haemoptysis  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Hiccups  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Hyperventilation  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Laryngospasm  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Lung Infiltration  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Pneumonitis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Pneumothorax  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Pulmonary Artery Thrombosis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Respiratory Failure  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Skin and subcutaneous tissue disorders       
Petechiae  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Purpura  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Vascular disorders       
Hypertension  1  8/214 (3.74%)  6/500 (1.20%)  2/358 (0.56%) 
Deep Vein Thrombosis  1  2/214 (0.93%)  3/500 (0.60%)  1/358 (0.28%) 
Aortic Thrombosis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Femoral Artery Occlusion  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Hypertensive Crisis  1  1/214 (0.47%)  1/500 (0.20%)  0/358 (0.00%) 
Orthostatic Hypotension  1  1/214 (0.47%)  0/500 (0.00%)  1/358 (0.28%) 
Peripheral Embolism  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Peripheral Ischaemia  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Phlebitis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Thrombosis  1  1/214 (0.47%)  0/500 (0.00%)  0/358 (0.00%) 
Vena Cava Thrombosis  1  0/214 (0.00%)  1/500 (0.20%)  0/358 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cediranib 30mg Cediranib 20mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   209/214 (97.66%)   485/500 (97.00%)   341/358 (95.25%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  56/214 (26.17%)  139/500 (27.80%)  84/358 (23.46%) 
Neutropenia  1  49/214 (22.90%)  138/500 (27.60%)  75/358 (20.95%) 
Leukopenia  1  15/214 (7.01%)  84/500 (16.80%)  39/358 (10.89%) 
Anaemia  1  24/214 (11.21%)  40/500 (8.00%)  43/358 (12.01%) 
Granulocytopenia  1  3/214 (1.40%)  28/500 (5.60%)  9/358 (2.51%) 
Endocrine disorders       
Hypothyroidism  1  28/214 (13.08%)  42/500 (8.40%)  8/358 (2.23%) 
Gastrointestinal disorders       
Diarrhoea  1  147/214 (68.69%)  346/500 (69.20%)  165/358 (46.09%) 
Nausea  1  92/214 (42.99%)  256/500 (51.20%)  169/358 (47.21%) 
Vomiting  1  83/214 (38.79%)  230/500 (46.00%)  126/358 (35.20%) 
Abdominal Pain  1  32/214 (14.95%)  134/500 (26.80%)  78/358 (21.79%) 
Stomatitis  1  59/214 (27.57%)  118/500 (23.60%)  48/358 (13.41%) 
Constipation  1  34/214 (15.89%)  85/500 (17.00%)  78/358 (21.79%) 
Abdominal Pain Upper  1  24/214 (11.21%)  58/500 (11.60%)  28/358 (7.82%) 
Dyspepsia  1  18/214 (8.41%)  35/500 (7.00%)  20/358 (5.59%) 
Abdominal Distension  1  6/214 (2.80%)  27/500 (5.40%)  19/358 (5.31%) 
Flatulence  1  4/214 (1.87%)  27/500 (5.40%)  12/358 (3.35%) 
General disorders       
Fatigue  1  80/214 (37.38%)  200/500 (40.00%)  104/358 (29.05%) 
Pyrexia  1  31/214 (14.49%)  76/500 (15.20%)  60/358 (16.76%) 
Asthenia  1  32/214 (14.95%)  74/500 (14.80%)  45/358 (12.57%) 
Oedema Peripheral  1  22/214 (10.28%)  53/500 (10.60%)  46/358 (12.85%) 
Immune system disorders       
Drug Hypersensitivity  1  6/214 (2.80%)  24/500 (4.80%)  19/358 (5.31%) 
Infections and infestations       
Urinary Tract Infection  1  15/214 (7.01%)  40/500 (8.00%)  14/358 (3.91%) 
Investigations       
Weight Decreased  1  28/214 (13.08%)  63/500 (12.60%)  18/358 (5.03%) 
Alanine Aminotransferase Increased  1  11/214 (5.14%)  33/500 (6.60%)  15/358 (4.19%) 
Aspartate Aminotransferase Increased  1  9/214 (4.21%)  33/500 (6.60%)  18/358 (5.03%) 
Platelet Count Decreased  1  6/214 (2.80%)  33/500 (6.60%)  17/358 (4.75%) 
Metabolism and nutrition disorders       
Decreased Appetite  1  92/214 (42.99%)  229/500 (45.80%)  125/358 (34.92%) 
Hypokalaemia  1  19/214 (8.88%)  58/500 (11.60%)  22/358 (6.15%) 
Musculoskeletal and connective tissue disorders       
Pain In Extremity  1  14/214 (6.54%)  48/500 (9.60%)  14/358 (3.91%) 
Back Pain  1  17/214 (7.94%)  41/500 (8.20%)  19/358 (5.31%) 
Arthralgia  1  15/214 (7.01%)  34/500 (6.80%)  14/358 (3.91%) 
Musculoskeletal Pain  1  13/214 (6.07%)  22/500 (4.40%)  12/358 (3.35%) 
Nervous system disorders       
Peripheral Sensory Neuropathy  1  45/214 (21.03%)  141/500 (28.20%)  89/358 (24.86%) 
Paraesthesia  1  49/214 (22.90%)  97/500 (19.40%)  85/358 (23.74%) 
Neuropathy Peripheral  1  24/214 (11.21%)  77/500 (15.40%)  64/358 (17.88%) 
Headache  1  35/214 (16.36%)  70/500 (14.00%)  34/358 (9.50%) 
Dizziness  1  19/214 (8.88%)  52/500 (10.40%)  23/358 (6.42%) 
Hypoaesthesia  1  7/214 (3.27%)  38/500 (7.60%)  17/358 (4.75%) 
Dysgeusia  1  14/214 (6.54%)  26/500 (5.20%)  25/358 (6.98%) 
Dysaesthesia  1  13/214 (6.07%)  16/500 (3.20%)  11/358 (3.07%) 
Psychiatric disorders       
Insomnia  1  15/214 (7.01%)  50/500 (10.00%)  27/358 (7.54%) 
Renal and urinary disorders       
Proteinuria  1  20/214 (9.35%)  60/500 (12.00%)  12/358 (3.35%) 
Respiratory, thoracic and mediastinal disorders       
Dysphonia  1  39/214 (18.22%)  67/500 (13.40%)  4/358 (1.12%) 
Epistaxis  1  37/214 (17.29%)  63/500 (12.60%)  31/358 (8.66%) 
Cough  1  24/214 (11.21%)  50/500 (10.00%)  35/358 (9.78%) 
Dyspnoea  1  14/214 (6.54%)  29/500 (5.80%)  24/358 (6.70%) 
Oropharyngeal Pain  1  12/214 (5.61%)  28/500 (5.60%)  6/358 (1.68%) 
Hiccups  1  11/214 (5.14%)  23/500 (4.60%)  8/358 (2.23%) 
Skin and subcutaneous tissue disorders       
Palmar-Plantar Erythrodysaesthesia Syndrome  1  53/214 (24.77%)  123/500 (24.60%)  57/358 (15.92%) 
Alopecia  1  18/214 (8.41%)  38/500 (7.60%)  22/358 (6.15%) 
Skin Hyperpigmentation  1  9/214 (4.21%)  34/500 (6.80%)  25/358 (6.98%) 
Rash  1  9/214 (4.21%)  33/500 (6.60%)  19/358 (5.31%) 
Dry Skin  1  14/214 (6.54%)  16/500 (3.20%)  11/358 (3.07%) 
Vascular disorders       
Hypertension  1  96/214 (44.86%)  226/500 (45.20%)  41/358 (11.45%) 
Phlebitis  1  7/214 (3.27%)  19/500 (3.80%)  18/358 (5.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00399035     History of Changes
Other Study ID Numbers: D8480C00051
EUDRACT No 2006-001194-14
HORIZON II
First Submitted: November 13, 2006
First Posted: November 14, 2006
Results First Submitted: March 29, 2012
Results First Posted: October 30, 2012
Last Update Posted: December 28, 2016