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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569AM2)(COMPLETED)
This study has been completed.
Study NCT00048724   Information provided by Schering-Plough
First Received: November 6, 2002   Last Updated: October 13, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Uncontrolled, Parallel Assignment
Conditions: Chronic Hepatitis C
Cirrhosis
Intervention: Biological: peginterferon alfa-2b (SCH 54031)

  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
Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.

Reporting Groups
  Description
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.

Participant Flow:   Overall Study
  PegIntron Untreated Control
STARTED   311     315  
COMPLETED   195     197  
NOT COMPLETED   116     118  
      Adverse Event               53                 12  
      Withdrawal by Subject               34                 54  
      Lost to Follow-up               5                 5  
      Protocol-defined Clinical Event               17                 32  
      Noncompliance With Protocol               4                 12  
      Did Not Meet Protocol Eligibility               2                 2  
      Administrative               1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.

Baseline Measures
  PegIntron Untreated Control Total
Number of Participants  
[units: participants]
 		311 315 626
Age, Customized  
[units: Participants]
 		     
<=50 years 130 132 262
>50 years 181 183 364
Gender  
[units: Participants]
 		     
Female 105 100 205
Male 206 215 421



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Observation of the First Clinical Event Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]
  Show Outcome Measure 1

2.  Secondary:   Time to Observation of the Disease Progression Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]
  Show Outcome Measure 2


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
PegIntron No text entered.
Untreated Control No text entered.

Serious Adverse Events
  PegIntron Untreated Control
Total, serious adverse events    
# participants affected / at risk 93/311 (29.90%)   74/315 (23.49%)  
Blood and lymphatic system disorders    
ANAEMIA   † A
      # participants affected / at risk
      # events
4/311 (1.29%)
5  
1/315 (0.32%)
2  
AUTOIMMUNE THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
FEBRILE NEUTROPENIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Cardiac disorders    
ACUTE MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ANGINA PECTORIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ARRHYTHMIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
ATRIOVENTRICULAR BLOCK COMPLETE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CARDIAC FAILURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CORONARY ARTERY DISEASE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
MITRAL VALVE INCOMPETENCE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Ear and labyrinth disorders    
HEARING IMPAIRED   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
TINNITUS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
VERTIGO   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Eye disorders    
CATARACT NUCLEAR   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
DIABETIC RETINOPATHY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
RETINAL DETACHMENT   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
VITREOUS HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Gastrointestinal disorders    
ABDOMINAL PAIN   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ABDOMINAL PAIN LOWER   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
3/315 (0.95%)
3  
ASCITES   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
3/315 (0.95%)
3  
CONSTIPATION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
DIARRHOEA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
ENTERITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
GASTRIC ULCER HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
GASTRIC VARICES HAEMORRHAGE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
GASTRITIS EROSIVE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
GASTROINTESTINAL HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
2  
1/315 (0.32%)
2  
GINGIVAL BLEEDING   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
HAEMATEMESIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
2/315 (0.63%)
2  
HAEMORRHOIDS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HERNIAL EVENTRATION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ILEITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
INGUINAL HERNIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
INTESTINAL OBSTRUCTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MALLORY-WEISS SYNDROME   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
MELAENA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
NAUSEA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
2/315 (0.63%)
2  
OESOPHAGEAL ULCER   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
OESOPHAGEAL VARICES HAEMORRHAGE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
10/315 (3.17%)
10  
PANCREATITIS ACUTE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
PERITONITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
RECTAL FISSURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
UMBILICAL HERNIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
UPPER GASTROINTESTINAL HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
VARICES OESOPHAGEAL   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
4/315 (1.27%)
8  
General disorders    
CHEST PAIN   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
DEATH   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
DISEASE PROGRESSION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
GENERAL PHYSICAL HEALTH DETERIORATION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
INFLUENZA LIKE ILLNESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MALAISE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MULTI-ORGAN FAILURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
NON-CARDIAC CHEST PAIN   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
OEDEMA PERIPHERAL   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
3  
1/315 (0.32%)
1  
PYREXIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
Hepatobiliary disorders    
BILIARY COLIC   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CHOLECYSTITIS   † A
      # participants affected / at risk
      # events
3/311 (0.96%)
3  
3/315 (0.95%)
3  
CHOLECYSTITIS ACUTE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CHOLELITHIASIS   † A
      # participants affected / at risk
      # events
4/311 (1.29%)
4  
0/315 (0.00%)
0  
CHRONIC HEPATIC FAILURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
HEPATIC CIRRHOSIS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
HEPATIC FAILURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
HEPATIC MASS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
JAUNDICE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
LIVER DISORDER   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
PORTAL HYPERTENSIVE GASTROPATHY   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Infections and infestations    
ABDOMINAL WALL ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
APPENDICITIS   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
BACTERAEMIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
BRONCHIECTASIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
BRONCHITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
CELLULITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ENDOCARDITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ENDOCARDITIS BACTERIAL   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ESCHERICHIA URINARY TRACT INFECTION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
FEBRILE INFECTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
GASTROENTERITIS   † A
      # participants affected / at risk
      # events
4/311 (1.29%)
4  
0/315 (0.00%)
0  
HAEMOPHILUS SEPSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
INTERVERTEBRAL DISCITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
LUNG ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MENINGITIS VIRAL   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
OESOPHAGEAL CANDIDIASIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PILONIDAL CYST   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PNEUMONIA   † A
      # participants affected / at risk
      # events
4/311 (1.29%)
4  
1/315 (0.32%)
1  
POSTOPERATIVE WOUND INFECTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PSOAS ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PYELONEPHRITIS   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
3  
0/315 (0.00%)
0  
RECTAL ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
SEPSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
SEPTIC SHOCK   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
SUBCUTANEOUS ABSCESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
TOOTH INFECTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
TUBERCULOSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
URINARY TRACT INFECTION   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
Injury, poisoning and procedural complications    
ANKLE FRACTURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
CERVICAL VERTEBRAL FRACTURE   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
4  
0/315 (0.00%)
0  
CONCUSSION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
DISLOCATION OF VERTEBRA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
FALL   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
1/315 (0.32%)
1  
FIBULA FRACTURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
FOOT FRACTURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HEAD INJURY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
INJURY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
LUMBAR VERTEBRAL FRACTURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MENISCUS LESION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
NECK INJURY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
OVERDOSE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
POST PROCEDURAL FISTULA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
POSTOPERATIVE FEVER   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
RIB FRACTURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
SKIN LACERATION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
SKULL FRACTURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
THERMAL BURN   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
TIBIA FRACTURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
WOUND SECRETION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
WRIST FRACTURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Investigations    
ALPHA 1 FOETOPROTEIN INCREASED   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
3/315 (0.95%)
3  
PLATELET COUNT DECREASED   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
TRANSPLANT EVALUATION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Metabolism and nutrition disorders    
ANOREXIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
DEHYDRATION   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
DIABETES MELLITUS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
DIABETES MELLITUS INADEQUATE CONTROL   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
DIABETES WITH HYPEROSMOLARITY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HYPOMAGNESAEMIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
TYPE 2 DIABETES MELLITUS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
Musculoskeletal and connective tissue disorders    
ARTHRALGIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
BACK PAIN   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
EXTRASKELETAL OSSIFICATION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
FOOT DEFORMITY   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
INTERVERTEBRAL DISC PROTRUSION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
LUMBAR SPINAL STENOSIS   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
NECK PAIN   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
OSTEOARTHRITIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
OSTEONECROSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
SYSTEMIC LUPUS ERYTHEMATOSUS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
BASAL CELL CARCINOMA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
BREAST CANCER   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
BREAST CANCER METASTATIC   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
COLON CANCER   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HEPATIC NEOPLASM   † A
      # participants affected / at risk
      # events
3/311 (0.96%)
4  
2/315 (0.63%)
2  
HEPATIC NEOPLASM MALIGNANT   † A
      # participants affected / at risk
      # events
11/311 (3.54%)
12  
12/315 (3.81%)
12  
LYMPHOMA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
MALIGNANT MELANOMA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
MALIGNANT PALATE NEOPLASM   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MULTIPLE MYELOMA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
OROPHARYNGEAL CANCER STAGE UNSPECIFIED   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PROSTATE CANCER   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
RECTAL CANCER   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
SALIVARY GLAND ADENOMA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
UTERINE LEIOMYOMA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Nervous system disorders    
CARPAL TUNNEL SYNDROME   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CEREBRAL CYST   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
CEREBRAL INFARCTION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
CEREBROVASCULAR ACCIDENT   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
CONVULSION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
ENCEPHALOPATHY   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
EPILEPSY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HEADACHE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
HEPATIC ENCEPHALOPATHY   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
2/315 (0.63%)
2  
HYPERTONIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
INTRACRANIAL ANEURYSM   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
LOSS OF CONSCIOUSNESS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
MENINGORRHAGIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
SUBARACHNOID HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
SYNCOPE   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
3  
0/315 (0.00%)
0  
Psychiatric disorders    
ALCOHOL ABUSE   † A
      # participants affected / at risk
      # events
3/311 (0.96%)
3  
1/315 (0.32%)
1  
BRADYPHRENIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
DELIRIUM   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
DEPRESSION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
SUICIDAL IDEATION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
Renal and urinary disorders    
CALCULUS URINARY   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
NEPHROLITHIASIS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
RENAL COLIC   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
RENAL FAILURE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
URINARY RETENTION   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
2  
0/315 (0.00%)
0  
Reproductive system and breast disorders    
BENIGN PROSTATIC HYPERPLASIA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
BREAST CALCIFICATIONS   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
CYSTOCELE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MENORRHAGIA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
OVARIAN CYST   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
UTERINE HAEMORRHAGE   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
UTERINE PROLAPSE   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
Respiratory, thoracic and mediastinal disorders    
CHRONIC OBSTRUCTIVE PULMONARY DISEASE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
2  
0/315 (0.00%)
0  
DYSPNOEA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
HAEMOPTYSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
INTERSTITIAL LUNG DISEASE   † A
      # participants affected / at risk
      # events
3/311 (0.96%)
3  
0/315 (0.00%)
0  
LUNG DISORDER   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
MIDDLE LOBE SYNDROME   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
PLEURAL EFFUSION   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
PULMONARY HYPERTENSION   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
0/315 (0.00%)
0  
RESPIRATORY FAILURE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
1/315 (0.32%)
1  
SLEEP APNOEA SYNDROME   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Skin and subcutaneous tissue disorders    
RASH   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Surgical and medical procedures    
POST PROCEDURAL DRAINAGE   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
Vascular disorders    
ARTERIOSCLEROSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
FEMORAL ARTERIAL STENOSIS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
2/315 (0.63%)
2  
HAEMATOMA   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
HYPERTENSION   † A
      # participants affected / at risk
      # events
2/311 (0.64%)
2  
1/315 (0.32%)
1  
ILIAC ARTERY STENOSIS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
LYMPHOEDEMA   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PELVIC VENOUS THROMBOSIS   † A
      # participants affected / at risk
      # events
1/311 (0.32%)
1  
0/315 (0.00%)
0  
PERIPHERAL VASCULAR DISORDER   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
VARICOSE VEIN   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
VASCULITIS   † A
      # participants affected / at risk
      # events
0/311 (0.00%)
0  
1/315 (0.32%)
1  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 11.0


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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
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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure )
Study ID Numbers: P02569
Study First Received: November 6, 2002
Results First Received: April 23, 2009
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00048724     History of Changes
Health Authority: United States: Food and Drug Administration





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