Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01103323
First received: April 8, 2010
Last updated: January 23, 2014
Last verified: January 2014
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Placebo

  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
No text entered.

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
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Placebo Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle

Participant Flow:   Overall Study
    Regorafenib (Stivarga, BAY73-4506)     Placebo  
STARTED     505     255  
Participants Received Treatment     500     253  
COMPLETED     386     232  
NOT COMPLETED     119     23  
Adverse Event                 42                 7  
Withdrawal by Subject                 16                 5  
Protocol Violation                 2                 0  
Physician Decision                 2                 0  
ongoing with treatment                 52                 9  
did not receive study treatment                 5                 2  



  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
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Placebo Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Total Total of all reporting groups

Baseline Measures
    Regorafenib (Stivarga, BAY73-4506)     Placebo     Total  
Number of Participants  
[units: participants]
  505     255     760  
Age [1]
[units: Years]
Mean ( Full Range )
  60.7  
  ( 22 to 82 )  
  60.1  
  ( 25 to 85 )  
  60.5  
  ( 22 to 85 )  
Gender  
[units: Participants]
     
Female     194     102     296  
Male     311     153     464  
Eastern Cooperative Oncology Group (ECOG) performance status (PS) before treatment [2]
[units: Participants]
     
0     265     146     411  
1     240     109     349  
KRAS mutation [3]
[units: Participants]
     
No     205     94     299  
Yes     273     157     430  
Unknown     27     4     31  
[1] The age of the patient in years at enrollment in the study.
[2] ECOG PS is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare; 3= Capable of limited selfcare; 4= Completely disabled; 5= Dead
[3] KRAS - Kirsten rat sarcoma viral oncogene homolog (protein), member of the RAS family of GTPases (guanosine triphosphate hydrolases)



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA). ]

2.  Secondary:   Progression-free Survival (Based on Investigator’s Assessment)   [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

3.  Secondary:   Objective Tumor Response   [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

4.  Secondary:   Disease Control   [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

5.  Secondary:   Tumor Response   [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Disseminated Intravascular Coagulation (DIC), International Normalized Ratio (INR), Cardiac Troponin T (cTnT), Gastroihntestina (GI), Not Otherwise Specified (NOS), Aspartate Aminotransferase (AST), Genitourinary (GU), Alanine Aminotransferase (ALT), Acute Respiratory Distress Syndrome (ARDS), Absolute Neutrophil Count (ANC)

Reporting Groups
  Description
Regorafenib (Stivarga, BAY73-4506) Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Placebo Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle

Serious Adverse Events
    Regorafenib (Stivarga, BAY73-4506)     Placebo  
Total, serious adverse events      
# participants affected / at risk     220/500 (44.00%)     101/253 (39.92%)  
Blood and lymphatic system disorders      
DIC * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Edema: Limb * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Edema: Trunk/Genital * 1    
# participants affected / at risk     0/500 (0.00%)     2/253 (0.79%)  
# events     0     4  
Edema: Viscera * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     3  
Hemoglobin * 1    
# participants affected / at risk     4/500 (0.80%)     2/253 (0.79%)  
# events     8     2  
INR * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     5     0  
Neutrophils * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Platelets * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Thrombotic Microangiopathy * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Cardiac disorders      
Cardiac Arrhythmia - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Cardiac General - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Cardiac Ischemia/Infarction * 1    
# participants affected / at risk     6/500 (1.20%)     1/253 (0.40%)  
# events     6     2  
Hypertension * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hypotension * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Supraventricular Arrhythmia, Atrial Fibrillation * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
cTnT * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Eye disorders      
Diplopia * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Ocular - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Anorexia * 1    
# participants affected / at risk     4/500 (0.80%)     2/253 (0.79%)  
# events     6     2  
Ascites * 1    
# participants affected / at risk     1/500 (0.20%)     2/253 (0.79%)  
# events     2     2  
Constipation * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Dehydration * 1    
# participants affected / at risk     3/500 (0.60%)     2/253 (0.79%)  
# events     3     2  
Diarrhea * 1    
# participants affected / at risk     8/500 (1.60%)     0/253 (0.00%)  
# events     9     0  
Distension * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Enteritis * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Fistula, GI, Abdomen NOS * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     2     1  
Fistula, GI, Anus * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Fistula, GI, Small Bowel NOS * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
GI - Other * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Hemorrhoids * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Ileus * 1    
# participants affected / at risk     2/500 (0.40%)     3/253 (1.19%)  
# events     3     3  
Mucositis (Functional/Symptomatic), Small Bowel * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Necrosis, GI, Peritoneal Cavity * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Obstruction, GI, Colon * 1    
# participants affected / at risk     9/500 (1.80%)     6/253 (2.37%)  
# events     11     8  
Obstruction, GI, Ileum * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Obstruction, GI, Small Bowel NOS * 1    
# participants affected / at risk     3/500 (0.60%)     7/253 (2.77%)  
# events     4     9  
Obstruction, GI, Stomach * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Perforation, GI, Colon * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Stricture, GI, Biliary Tree * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Ulcer, GI, Duodenum * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Vomiting * 1    
# participants affected / at risk     3/500 (0.60%)     0/253 (0.00%)  
# events     3     0  
General disorders      
Constitutional Symptoms - Other * 1    
# participants affected / at risk     32/500 (6.40%)     23/253 (9.09%)  
# events     47     39  
Death Not Associated With CTCAE Term, Disease Progression NOS * 1    
# participants affected / at risk     15/500 (3.00%)     6/253 (2.37%)  
# events     16     6  
Death Not Associated With CTCAE Term, Multi-Organ Failure * 1    
# participants affected / at risk     4/500 (0.80%)     1/253 (0.40%)  
# events     4     1  
Death Not Associated With CTCAE Term, Sudden Death * 1    
# participants affected / at risk     2/500 (0.40%)     2/253 (0.79%)  
# events     2     2  
Fatigue * 1    
# participants affected / at risk     4/500 (0.80%)     5/253 (1.98%)  
# events     5     5  
Fever * 1    
# participants affected / at risk     16/500 (3.20%)     2/253 (0.79%)  
# events     20     2  
Pain, Abdomen NOS * 1    
# participants affected / at risk     13/500 (2.60%)     2/253 (0.79%)  
# events     21     2  
Pain, Back * 1    
# participants affected / at risk     3/500 (0.60%)     4/253 (1.58%)  
# events     5     5  
Pain, Buttock * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     4     0  
Pain, Cardiac/Heart * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Pain, Chest/Thorax NOS * 1    
# participants affected / at risk     3/500 (0.60%)     1/253 (0.40%)  
# events     3     1  
Pain, Extremity - Limb * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     6     0  
Pain, Head/Headache * 1    
# participants affected / at risk     2/500 (0.40%)     1/253 (0.40%)  
# events     2     1  
Pain, Joint * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Pain, Liver * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Pain, Neuralgia/Peripheral Nerve * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Pain, Pain NOS * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Pain, Tumor Pain * 1    
# participants affected / at risk     2/500 (0.40%)     1/253 (0.40%)  
# events     2     1  
Syndromes - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Tumor Flare * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Weight Loss * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Hepatobiliary disorders      
Cholecystitis * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hepatobiliary - Other * 1    
# participants affected / at risk     2/500 (0.40%)     1/253 (0.40%)  
# events     2     1  
Liver Dysfunction * 1    
# participants affected / at risk     17/500 (3.40%)     4/253 (1.58%)  
# events     28     9  
Immune system disorders      
Allergic Reaction * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     4     0  
Infections and infestations      
Infection (Documented Clinically), Abdomen NOS * 1    
# participants affected / at risk     4/500 (0.80%)     0/253 (0.00%)  
# events     4     0  
Infection (Documented Clinically), Anal/Perianal * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection (Documented Clinically), Appendix * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection (Documented Clinically), Bladder (Urinary) * 1    
# participants affected / at risk     2/500 (0.40%)     1/253 (0.40%)  
# events     2     1  
Infection (Documented Clinically), Blood * 1    
# participants affected / at risk     2/500 (0.40%)     2/253 (0.79%)  
# events     4     2  
Infection (Documented Clinically), Bronchus * 1    
# participants affected / at risk     3/500 (0.60%)     0/253 (0.00%)  
# events     3     0  
Infection (Documented Clinically), Catheter-Related * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Infection (Documented Clinically), Kidney * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Infection (Documented Clinically), Lung (Pneumonia) * 1    
# participants affected / at risk     9/500 (1.80%)     3/253 (1.19%)  
# events     11     4  
Infection (Documented Clinically), Skin (Cellulitis) * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection (Documented Clinically), Soft Tissue NOS * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection (Documented Clinically), Urinary Tract NOS * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Infection (Documented Clinically), Wound * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection - Other * 1    
# participants affected / at risk     5/500 (1.00%)     1/253 (0.40%)  
# events     6     2  
Infection With Normal ANC, Blood * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Infection With Normal ANC, Catheter-Related * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection With Normal ANC, Gallbladder (Cholecystitis) * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection With Normal ANC, Kidney * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection With Normal ANC, Lung (Pneumonia) * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Infection With Normal ANC, Soft Tissue NOS * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Infection With Unknown ANC, Kidney * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Infection With Unknown ANC, Lung (Pneumonia) * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Metabolism and nutrition disorders      
AST * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Bilirubin (Hyperbilirubinemia) * 1    
# participants affected / at risk     8/500 (1.60%)     4/253 (1.58%)  
# events     11     4  
Hypoalbuminemia * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hypocalcemia * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Hyponatremia * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Metabolic/Lab - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
Fracture * 1    
# participants affected / at risk     3/500 (0.60%)     2/253 (0.79%)  
# events     3     3  
Gait/Walking * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Muscle Weakness Left-Sided * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Muscle Weakness, Extremity - Lower * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Muscle Weakness, Whole Body/Generalized * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Musculoskeletal - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Myositis * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Nervous system disorders      
Ataxia * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
CNS Ischemia * 1    
# participants affected / at risk     1/500 (0.20%)     2/253 (0.79%)  
# events     2     2  
Cognitive Disturbance * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Confusion * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Dizziness * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Encephalopathy * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Neurology - Other * 1    
# participants affected / at risk     2/500 (0.40%)     3/253 (1.19%)  
# events     3     3  
Neuropathy: Cranial, CN III Pupil, upper Eyelid, extra Ocular Mov * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Neuropathy: Motor * 1    
# participants affected / at risk     3/500 (0.60%)     0/253 (0.00%)  
# events     3     0  
Seizure * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Somnolence * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Speech Impairment * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Syncope (Fainting) * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Renal and urinary disorders      
Cystitis * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Fistula, GU, Bladder * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Obstruction, GU, Ureter * 1    
# participants affected / at risk     2/500 (0.40%)     1/253 (0.40%)  
# events     2     1  
Renal - Other * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Renal Failure * 1    
# participants affected / at risk     5/500 (1.00%)     3/253 (1.19%)  
# events     6     5  
Urinary Retention * 1    
# participants affected / at risk     0/500 (0.00%)     2/253 (0.79%)  
# events     0     2  
Respiratory, thoracic and mediastinal disorders      
ARDS * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Cough * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Dyspnea (Shortness Of Breath) * 1    
# participants affected / at risk     12/500 (2.40%)     4/253 (1.58%)  
# events     18     4  
Pleural Effusion * 1    
# participants affected / at risk     1/500 (0.20%)     3/253 (1.19%)  
# events     2     3  
Pneumonitis * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Pneumothorax * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     3     0  
Pulmonary - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Skin and subcutaneous tissue disorders      
Dermatology - Other * 1    
# participants affected / at risk     0/500 (0.00%)     2/253 (0.79%)  
# events     0     3  
Erythema Multiforme * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Hand-Foot Skin Reaction * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     3     0  
Rash/Desquamation * 1    
# participants affected / at risk     4/500 (0.80%)     1/253 (0.40%)  
# events     7     1  
Wound Complication, Non-Infectious * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Vascular disorders      
Hematoma * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Hemorrhage - Other * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     2     0  
Hemorrhage Pulmonary, Bronchus * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Hemorrhage, GI, Abdomen NOS * 1    
# participants affected / at risk     2/500 (0.40%)     0/253 (0.00%)  
# events     4     0  
Hemorrhage, GI, Anus * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Hemorrhage, GI, Lower GI NOS * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hemorrhage, GI, Rectum * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hemorrhage, GI, Stoma * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hemorrhage, GI, Varices (Esophageal) * 1    
# participants affected / at risk     0/500 (0.00%)     1/253 (0.40%)  
# events     0     1  
Hemorrhage, GI, Varices (Rectal) * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     1     0  
Hemorrhage, GU, Vagina * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
Thrombosis/Embolism (Vascular Access) * 1    
# participants affected / at risk     1/500 (0.20%)     1/253 (0.40%)  
# events     1     1  
Thrombosis/Thrombus/Embolism * 1    
# participants affected / at risk     4/500 (0.80%)     3/253 (1.19%)  
# events     4     5  
Vascular - Other * 1    
# participants affected / at risk     1/500 (0.20%)     0/253 (0.00%)  
# events     2     0  
* Events were collected by non-systematic assessment
1 Term from vocabulary, NCI-CTCAE v.3.0




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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
At 2nd IA, pre-specified O’Brien-Fleming-type efficacy boundary was crossed. DMC concluded OS result positive and after positive risk benefit assessment, recommended unblinding of study. OS from 2nd IA are the final formal and definitive results.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01103323     History of Changes
Other Study ID Numbers: 14387, 2009-012787-14
Study First Received: April 8, 2010
Results First Received: October 19, 2012
Last Updated: January 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: National Institute of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Switzerland: Swissmedic
Canada: Health Canada
Spain: Spanish Agency of Medicines
Portugal: National Pharmacy and Medicines Institute
Turkey: Ministry of Health
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Federal Agency for Medicinal Products and Health Products
United States: Food and Drug Administration