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Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)

This study has been completed.
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
NSABP Foundation Inc
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00561470
First received: November 20, 2007
Last updated: September 27, 2012
Last verified: March 2012
Results First Received: August 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Interventions: Drug: Placebo
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 19 November 2007 and 16 March 2010, 614 participants were randomized to the placebo arm and 612 participants were randomized to the aflibercept arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo/FOLFIRI Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Aflibercept/FOLFIRI Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

Participant Flow:   Overall Study
    Placebo/FOLFIRI   Aflibercept/FOLFIRI
STARTED   614   612 
TREATED   609   607 
SAFETY POPULATION   605 [1]   611 [2] 
ONGOING TREATMENT   11 [3]   14 [3] 
COMPLETED   0 [4]   0 [4] 
NOT COMPLETED   614   612 
Adverse Event                74                163 
Disease progression                437                305 
poor compliance to protocol                4                4 
Lost to Follow-up                2                0 
Physician Decision                21                20 
Consent Withdrawn                2                6 
Subject request                43                77 
Metastatic surgery                10                12 
Unauthorized procedure                3                1 
Randomized but not treated                5                5 
Missed visit window                1                4 
Planning surgery                1                1 
Ongoing Treatment                11                14 
[1] Treated participants excluding 4 who received at least 1 dose of Aflibercept
[2] Treated participants including 4 from Placebo/FOLFIRI who received at least 1 dose of Aflibercept
[3] Participants continuing treatment on the cutoff date of the final analysis
[4] Participants met treatment discontinuation criteria or were ongoing treatment on the cutoff date



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo/Folfiri Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
Aflibercept/Folfiri Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
Total Total of all reporting groups

Baseline Measures
   Placebo/Folfiri   Aflibercept/Folfiri   Total 
Overall Participants Analyzed 
[Units: Participants]
 614   612   1226 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (10.8)   59.5  (10.5)   59.8  (10.7) 
Age, Customized 
[Units: Participants]
     
<65 years   376   407   783 
>=65 but <75 years   199   172   371 
>=75 years   39   33   72 
Gender, Customized 
[Units: Participants]
     
Male   353   365   718 
Female   261   247   508 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian/White   523   548   1071 
Black   27   16   43 
Asian/Oriental   51   35   86 
Other   13   13   26 
Region of Enrollment 
[Units: Participants]
     
ARGENTINA   4   2   6 
AUSTRALIA   42   54   96 
AUSTRIA   3   4   7 
BELGIUM   37   45   82 
BRAZIL   21   27   48 
CHILE   31   33   64 
CZECH REPUBLIC   30   47   77 
DENMARK   9   6   15 
ESTONIA   7   3   10 
FRANCE   1   1   2 
GERMANY   23   12   35 
GREECE   9   10   19 
ITALY   26   23   49 
KOREA, REPUBLIC OF   39   26   65 
NETHERLANDS   20   14   34 
NEW ZEALAND   13   7   20 
NORWAY   14   19   33 
POLAND   24   32   56 
PUERTO RICO   4   2   6 
ROMANIA   16   16   32 
RUSSIAN FEDERATION   35   40   75 
SOUTH AFRICA   36   31   67 
SPAIN   27   28   55 
SWEDEN   10   4   14 
TURKEY   4   2   6 
UKRAINE   11   11   22 
UNITED KINGDOM   47   52   99 
UNITED STATES   71   61   132 
Eastern Cooperative Oncology Group (ECOG) performance status score [1] 
[Units: Participants]
     
Participants with ECOG Score = 0   350   349   699 
Participants with ECOG Score = 1   250   250   500 
Participants with ECOG Score = 2   14   13   27 
[1] The ECOG score assesses how the disease affects a participant's daily living abilities. It ranges from 0-5, with 0 being the best and 5 being the worst outcome. "0" reflects a fully active participant, able to carry on all pre-disease performance without restriction. "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. "2" reflects an ambulatory participant, who is up and about more than 50% of waking hours, and capable of all self-care but unable to carry out any work activities.
Prior Bevacizumab [1] 
[Units: Participants]
     
Yes   187   186   373 
No   427   426   853 
[1] Number of participants randomized in the prior bevacizumab stratum as per the interactive voice response system (IVRS).


  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) ]

2.  Secondary:   Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)   [ Time Frame: From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months) ]

3.  Secondary:   Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria   [ Time Frame: From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months) ]

4.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized ]

5.  Secondary:   Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay   [ Time Frame: Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo ]


  Serious Adverse Events
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Time Frame From treatment initiation to 7 February, 2011
Additional Description No text entered.

Reporting Groups
  Description
Placebo/FOLFIRI Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Aflibercept/FOLFIRI Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

Serious Adverse Events
    Placebo/FOLFIRI   Aflibercept/FOLFIRI
Total, serious adverse events     
# participants affected / at risk   198/605 (32.73%)   294/611 (48.12%) 
Blood and lymphatic system disorders     
Neutropenia * 1     
# participants affected / at risk   4/605 (0.66%)   11/611 (1.80%) 
Thrombocytopenia * 1     
# participants affected / at risk   3/605 (0.50%)   2/611 (0.33%) 
Anaemia * 1     
# participants affected / at risk   3/605 (0.50%)   7/611 (1.15%) 
Febrile neutropenia * 1     
# participants affected / at risk   6/605 (0.99%)   19/611 (3.11%) 
Coagulopathy * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Pancytopenia * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Thrombotic microangiopathy * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Cardiac disorders     
Angina pectoris * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Atrial fibrillation * 1     
# participants affected / at risk   2/605 (0.33%)   3/611 (0.49%) 
Sinus bradycardia * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Acute myocardial infarction * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Myocardial ischaemia * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Cardiac failure congestive * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Intracardiac thrombus * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Myocardial infarction * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pericarditis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Endocrine disorders     
Hypercalcaemia of malignancy * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Eye disorders     
Periorbital oedema * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Gastrointestinal disorders     
Diarrhoea * 1     
# participants affected / at risk   14/605 (2.31%)   44/611 (7.20%) 
Nausea * 1     
# participants affected / at risk   3/605 (0.50%)   4/611 (0.65%) 
Stomatitis * 1     
# participants affected / at risk   0/605 (0.00%)   8/611 (1.31%) 
Vomiting * 1     
# participants affected / at risk   7/605 (1.16%)   10/611 (1.64%) 
Abdominal pain * 1     
# participants affected / at risk   7/605 (1.16%)   12/611 (1.96%) 
Constipation * 1     
# participants affected / at risk   4/605 (0.66%)   6/611 (0.98%) 
Abdominal pain upper * 1     
# participants affected / at risk   3/605 (0.50%)   4/611 (0.65%) 
Haemorrhoids * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Rectal haemorrhage * 1     
# participants affected / at risk   4/605 (0.66%)   6/611 (0.98%) 
Aphthous stomatitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Proctalgia * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Ascites * 1     
# participants affected / at risk   4/605 (0.66%)   3/611 (0.49%) 
Gastrooesophageal reflux disease * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Intestinal obstruction * 1     
# participants affected / at risk   11/605 (1.82%)   10/611 (1.64%) 
Abdominal pain lower * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Gastritis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Enteritis * 1     
# participants affected / at risk   1/605 (0.17%)   2/611 (0.33%) 
Gingivitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Ileus * 1     
# participants affected / at risk   5/605 (0.83%)   4/611 (0.65%) 
Colitis * 1     
# participants affected / at risk   1/605 (0.17%)   4/611 (0.65%) 
Small intestinal obstruction * 1     
# participants affected / at risk   2/605 (0.33%)   5/611 (0.82%) 
Anal haemorrhage * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Faecal incontinence * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Gastrointestinal haemorrhage * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Gastrointestinal inflammation * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Periodontitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Gastrointestinal obstruction * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Haematemesis * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Mechanical ileus * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Colitis ischaemic * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Colonic obstruction * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Duodenal ulcer perforation * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Peritonitis * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Small intestinal perforation * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Subileus * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Colonic fistula * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Duodenal obstruction * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Duodenal ulcer haemorrhage * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Enterocolitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Enterocutaneous fistula * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Gastrointestinal hypomotility * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Gastrointestinal perforation * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Ileal perforation * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Ileitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Large intestinal haemorrhage * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Large intestinal obstruction * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Lower gastrointestinal haemorrhage * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Mallory-weiss syndrome * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Mesenteric vein thrombosis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Neutropenic colitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pancreatitis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Rectal obstruction * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Rectal stenosis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
General disorders     
Fatigue * 1     
# participants affected / at risk   3/605 (0.50%)   2/611 (0.33%) 
Asthenia * 1     
# participants affected / at risk   4/605 (0.66%)   5/611 (0.82%) 
Pyrexia * 1     
# participants affected / at risk   15/605 (2.48%)   10/611 (1.64%) 
Oedema peripheral * 1     
# participants affected / at risk   3/605 (0.50%)   0/611 (0.00%) 
Disease progression * 1     
# participants affected / at risk   14/605 (2.31%)   16/611 (2.62%) 
Pain * 1     
# participants affected / at risk   1/605 (0.17%)   2/611 (0.33%) 
Non-cardiac chest pain * 1     
# participants affected / at risk   1/605 (0.17%)   2/611 (0.33%) 
Malaise * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Thrombosis in device * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
General physical health deterioration * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Medical device complication * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Death * 1     
# participants affected / at risk   1/605 (0.17%)   2/611 (0.33%) 
Suprapubic pain * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Mucosal inflammation * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Sudden death * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1     
# participants affected / at risk   4/605 (0.66%)   2/611 (0.33%) 
Cholecystitis * 1     
# participants affected / at risk   1/605 (0.17%)   4/611 (0.65%) 
Biliary colic * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Cholangitis * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Hepatic function abnormal * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Jaundice cholestatic * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Bile duct obstruction * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Hepatic haemorrhage * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Hepatitis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Hepatotoxicity * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Immune system disorders     
Hypersensitivity * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Infections and infestations     
Urinary tract infection * 1     
# participants affected / at risk   3/605 (0.50%)   8/611 (1.31%) 
Upper respiratory tract infection * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pneumonia * 1     
# participants affected / at risk   5/605 (0.83%)   11/611 (1.80%) 
Lower respiratory tract infection * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Device related infection * 1     
# participants affected / at risk   6/605 (0.99%)   5/611 (0.82%) 
Bronchitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Cystitis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Oral candidiasis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Neutropenic infection * 1     
# participants affected / at risk   5/605 (0.83%)   4/611 (0.65%) 
Sinusitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Viral infection * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Pharyngitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Respiratory tract infection * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Sepsis * 1     
# participants affected / at risk   5/605 (0.83%)   8/611 (1.31%) 
Gastroenteritis * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Catheter site infection * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Infection * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Lobar pneumonia * 1     
# participants affected / at risk   5/605 (0.83%)   0/611 (0.00%) 
Lung infection * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Anal abscess * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Diverticulitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Neutropenic sepsis * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Perirectal abscess * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Subcutaneous abscess * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Abscess jaw * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Clostridial infection * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Oesophageal candidiasis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Septic shock * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Appendicitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Bacterial sepsis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Beta haemolytic streptococcal infection * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Bronchopneumonia * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Device related sepsis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Emphysematous cystitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Enterocolitis infectious * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Escherichia infection * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Pelvic abscess * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Perinephric abscess * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Peritonitis bacterial * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pneumonia streptococcal * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Rectal abscess * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Staphylococcal sepsis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Viral diarrhoea * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Post procedural haemorrhage * 1     
# participants affected / at risk   1/605 (0.17%)   2/611 (0.33%) 
Skin laceration * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Gastrointestinal stoma complication * 1     
# participants affected / at risk   0/605 (0.00%)   3/611 (0.49%) 
Head injury * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Incisional hernia * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Wound dehiscence * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Ankle fracture * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Femoral neck fracture * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Femur fracture * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Limb traumatic amputation * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pneumothorax traumatic * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Subdural haematoma * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Investigations     
Neutrophil count decreased * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Blood creatinine increased * 1     
# participants affected / at risk   2/605 (0.33%)   2/611 (0.33%) 
Blood bilirubin increased * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Haemoglobin decreased * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
International normalised ratio increased * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Blood creatine increased * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
C-reactive protein increased * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Hepatic enzyme increased * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Metabolism and nutrition disorders     
Decreased appetite * 1     
# participants affected / at risk   2/605 (0.33%)   3/611 (0.49%) 
Dehydration * 1     
# participants affected / at risk   7/605 (1.16%)   24/611 (3.93%) 
Diabetes mellitus * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Hypoglycaemia * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Hyponatraemia * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Failure to thrive * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Hypoproteinaemia * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1     
# participants affected / at risk   4/605 (0.66%)   3/611 (0.49%) 
Bone pain * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Musculoskeletal chest pain * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Bursitis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Osteonecrosis of jaw * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pathological fracture * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Fistula * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic pain * 1     
# participants affected / at risk   3/605 (0.50%)   2/611 (0.33%) 
Cancer pain * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Tumour pain * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Metastases to central nervous system * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Benign neoplasm of cervix uteri * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Bladder cancer * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Tumour associated fever * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Nervous system disorders     
Headache * 1     
# participants affected / at risk   1/605 (0.17%)   3/611 (0.49%) 
Peripheral sensory neuropathy * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Syncope * 1     
# participants affected / at risk   3/605 (0.50%)   1/611 (0.16%) 
Presyncope * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Transient ischaemic attack * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Migraine * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Spinal cord compression * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Aphasia * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Brachial plexopathy * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Cerebrovascular accident * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Coma * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Convulsion * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Disturbance in attention * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Haemorrhage intracranial * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Metabolic encephalopathy * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Psychiatric disorders     
Anxiety * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Depression * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Confusional state * 1     
# participants affected / at risk   2/605 (0.33%)   2/611 (0.33%) 
Hallucination * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Mental status changes * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Renal and urinary disorders     
Proteinuria * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Haematuria * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Urinary retention * 1     
# participants affected / at risk   1/605 (0.17%)   4/611 (0.65%) 
Urinary incontinence * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Hydronephrosis * 1     
# participants affected / at risk   3/605 (0.50%)   1/611 (0.16%) 
Renal failure acute * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Renal impairment * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Renal vein thrombosis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Bladder neck obstruction * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Nephrotic syndrome * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Renal failure * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Cystitis haemorrhagic * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Nephrolithiasis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Obstructive uropathy * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Urinary tract obstruction * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Balanitis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Cough * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Dyspnoea * 1     
# participants affected / at risk   3/605 (0.50%)   3/611 (0.49%) 
Oropharyngeal pain * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pulmonary embolism * 1     
# participants affected / at risk   12/605 (1.98%)   19/611 (3.11%) 
Pleural effusion * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pleuritic pain * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Atelectasis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Interstitial lung disease * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Pneumonitis * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Pneumothorax * 1     
# participants affected / at risk   0/605 (0.00%)   2/611 (0.33%) 
Acute pulmonary oedema * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Acute respiratory distress syndrome * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Acute respiratory failure * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pneumomediastinum * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pneumonia aspiration * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pulmonary artery thrombosis * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Pulmonary hypertension * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Vascular disorders     
Hypertension * 1     
# participants affected / at risk   0/605 (0.00%)   10/611 (1.64%) 
Deep vein thrombosis * 1     
# participants affected / at risk   7/605 (1.16%)   7/611 (1.15%) 
Hypotension * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Jugular vein thrombosis * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Vena cava thrombosis * 1     
# participants affected / at risk   2/605 (0.33%)   2/611 (0.33%) 
Pelvic venous thrombosis * 1     
# participants affected / at risk   2/605 (0.33%)   0/611 (0.00%) 
Orthostatic hypotension * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Subclavian vein thrombosis * 1     
# participants affected / at risk   2/605 (0.33%)   1/611 (0.16%) 
Circulatory collapse * 1     
# participants affected / at risk   1/605 (0.17%)   1/611 (0.16%) 
Thrombophlebitis * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Arterial thrombosis limb * 1     
# participants affected / at risk   1/605 (0.17%)   0/611 (0.00%) 
Embolism arterial * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Hypovolaemic shock * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
Superior vena caval occlusion * 1     
# participants affected / at risk   0/605 (0.00%)   1/611 (0.16%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 13.1




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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