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:

Bayer

ClinicalTrials.gov Identifier:

NCT01103323

First received: April 8, 2010

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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). ]

Show Outcome Measure 1

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. ]

Show Outcome Measure 2

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. ]

Show Outcome Measure 3

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. ]

Show Outcome Measure 4

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. ]

Show Outcome Measure 5

Serious Adverse Events

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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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