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PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED)
This study has been completed.
Study NCT00039871   Information provided by Schering-Plough
First Received: June 13, 2002   Last Updated: October 13, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions: Hepatitis
Hepatitis C, Chronic
Fibrosis
Liver Cirrhosis
Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: REBETOL (ribavirin; SCH 18908)

  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
Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.

Reporting Groups
  Description
PegIntron Plus Rebetol No text entered.

Participant Flow:   Overall Study
  PegIntron Plus Rebetol
STARTED   2312[1]
COMPLETED   928  
NOT COMPLETED   1384  
      Adverse Event               165  
      Lost to Follow-up               18  
      Protocol Violation               24  
      Withdrawal by Subject               97  
      Did not meet eligibility criteria               11  
      Administrative               1  
      Discontinued at Week 12 per protocol               1061  
      Never entered follow-up               7  
[1] Enrolled 2333; 21 subjects excluded due to GCP non-compliance



  Baseline Characteristics
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Reporting Groups
  Description
PegIntron Plus Rebetol No text entered.

Baseline Measures
  PegIntron Plus Rebetol
Number of Participants  
[units: participants]
 		2312
Age  
[units: number of subjects]
 		 
<=18 years 0
Between 18 and 65 years 2267
>=65 years 45
Age  
[units: years]
Mean ± Standard Deviation 		49.2 ± 8.1
Gender  
[units: number of subjects]
 		 
Female 662
Male 1650
Hepatitis C Virus (HCV) Genotype  
[units: number of participants]
 		 
Genotype 1 1859
Genotype 2 75
Genotype 3 293
Genotype 4 68
Nontypable 8
Missing 9
METAVIR Fibrosis score[1]
[units: number of participants]
 		 
F1 2
F2 658
F3 676
F4 974
Missing 2
[1]

The METAVIR scoring system for hepatic fibrosis is as follows:

  • F0= no fibrosis
  • F1 = portal fibrosis without septa
  • F2 = portal fibrosis with few septa
  • F3= septal fibrosis without cirrhosis
  • F4= cirrhosis



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Virologic Response (SVR) Rate   [ Assessed at end of 24 weeks posttreatment follow-up ]
  Show Outcome Measure 1

2.  Secondary:   Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12   [ 24 weeks posttreatment ]
  Show Outcome Measure 2

3.  Secondary:   Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12   [ 24 weeks posttreatment ]
  Show Outcome Measure 3


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

Reporting Groups
  Description
PegIntron Plus Rebetol No text entered.

Serious Adverse Events
  PegIntron Plus Rebetol
Total, serious adverse events  
# participants affected / at risk 200/2312 (8.65%)  
Blood and lymphatic system disorders  
ANAEMIA   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
AUTOIMMUNE THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LEUKOPENIA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
LYMPHADENOPATHY MEDIASTINAL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
NEUTROPENIA   † A
      # participants affected / at risk
      # events
7/2312 (0.30%)
9  
THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
THROMBOTIC THROMBOCYTOPENIC PURPURA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Cardiac disorders  
ACUTE MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ANGINA UNSTABLE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
ATRIAL FIBRILLATION   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
BUNDLE BRANCH BLOCK LEFT   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CARDIAC ARREST   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CARDIAC DISORDER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CARDIAC FAILURE CONGESTIVE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CORONARY ARTERY DISEASE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
PERICARDIAL EFFUSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
POSTINFARCTION ANGINA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Congenital, familial and genetic disorders  
HYDROCELE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Ear and labyrinth disorders  
DEAFNESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOACUSIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
MENIERE'S DISEASE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Endocrine disorders  
ADRENAL MASS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPERTHYROIDISM   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOTHYROIDISM   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Eye disorders  
CATARACT   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
4  
EYE INFLAMMATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
GLAUCOMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RETINAL ARTERY STENOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
2  
RETINAL HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VISION BLURRED   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
Gastrointestinal disorders  
ABDOMINAL PAIN   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
2  
ANAL FISSURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
APPENDICITIS PERFORATED   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
2  
ASCITES   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
DIARRHOEA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
DIVERTICULAR PERFORATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DYSPEPSIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
EROSIVE DUODENITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
GASTRIC ULCER HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
GASTRITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HAEMATEMESIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HAEMORRHOIDS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
INGUINAL HERNIA   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
MALLORY-WEISS SYNDROME   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
NAUSEA   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
OESOPHAGEAL ULCER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
OESOPHAGITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PANCREATITIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
SALIVARY GLAND CALCULUS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
UMBILICAL HERNIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VARICES OESOPHAGEAL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VOMITING   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
VOMITING PROJECTILE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
General disorders  
ASTHENIA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
CHEST PAIN   † A
      # participants affected / at risk
      # events
8/2312 (0.35%)
8  
DISEASE PROGRESSION   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
FATIGUE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
MULTI-ORGAN FAILURE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
NON-CARDIAC CHEST PAIN   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PYREXIA   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
Hepatobiliary disorders  
CHOLECYSTITIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
CHOLECYSTITIS ACUTE   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
CHOLELITHIASIS   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
HEPATIC CIRRHOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HEPATIC FAILURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HEPATIC LESION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HEPATORENAL SYNDROME   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYDROCHOLECYSTIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
JAUNDICE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Infections and infestations  
APPENDICITIS   † A
      # participants affected / at risk
      # events
6/2312 (0.26%)
6  
BACTERAEMIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
BOUTONNEUSE FEVER   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
BRONCHITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
BRONCHOPNEUMONIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CELLULITIS   † A
      # participants affected / at risk
      # events
7/2312 (0.30%)
7  
CELLULITIS STAPHYLOCOCCAL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CERVICITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DIVERTICULITIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
ERYSIPELAS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ESCHERICHIA SEPSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
FURUNCLE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
GASTROENTERITIS   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
GASTROENTERITIS SALMONELLA   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
LEPROSY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LOBAR PNEUMONIA   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
LUNG ABSCESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LUNG INFECTION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
NECROTISING FASCIITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
OTITIS MEDIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PELVIC INFLAMMATORY DISEASE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PERITONEAL ABSCESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PERITONITIS BACTERIAL   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
PNEUMONIA   † A
      # participants affected / at risk
      # events
10/2312 (0.43%)
10  
PNEUMONIA STAPHYLOCOCCAL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PYELONEPHRITIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
PYELONEPHRITIS ACUTE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
RENAL ABSCESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SEPSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SEPSIS SYNDROME   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SEPTIC SHOCK   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SINUSITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
STAPHYLOCOCCAL ABSCESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SUPERINFECTION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
TRACHEOBRONCHITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
UPPER RESPIRATORY TRACT INFECTION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Injury, poisoning and procedural complications  
ACCIDENT AT WORK   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ANIMAL BITE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ANKLE FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ARTHROPOD STING   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CLAVICLE FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CONCUSSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CONTUSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
EXTRADURAL HAEMATOMA   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
EYE INJURY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
FALL   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
FOOT FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
FOREIGN BODY TRAUMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HAND FRACTURE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
HEAD INJURY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HIP FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
INJURY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
INTENTIONAL OVERDOSE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
JAW FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LIGAMENT RUPTURE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
LUMBAR VERTEBRAL FRACTURE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
OVERDOSE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
POST PROCEDURAL COMPLICATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RADIUS FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RIB FRACTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ROAD TRAFFIC ACCIDENT   † A
      # participants affected / at risk
      # events
6/2312 (0.26%)
6  
SKIN LACERATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SKULL FRACTURED BASE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
STENT OCCLUSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
TENDON RUPTURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
WOUND DEHISCENCE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Investigations  
BLOOD PRESSURE ORTHOSTATIC   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HAEMOGLOBIN DECREASED   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
4  
Metabolism and nutrition disorders  
ANOREXIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DEHYDRATION   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
DIABETES MELLITUS INSULIN-DEPENDENT   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
2  
DIABETIC KETOACIDOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPERKALAEMIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOVOLAEMIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Musculoskeletal and connective tissue disorders  
INTERVERTEBRAL DISC PROTRUSION   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
MUSCULOSKELETAL CHEST PAIN   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
MYALGIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
NECK PAIN   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
OSTEOARTHRITIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
OSTEONECROSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PAIN IN JAW   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  
BILIARY ADENOMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HEPATIC NEOPLASM   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
HEPATIC NEOPLASM MALIGNANT   † A
      # participants affected / at risk
      # events
6/2312 (0.26%)
6  
PROSTATE CANCER   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
RENAL CELL CARCINOMA STAGE UNSPECIFIED   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SQUAMOUS CELL CARCINOMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
THYROID NEOPLASM   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
UTERINE LEIOMYOMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Nervous system disorders  
CEREBELLAR INFARCTION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CEREBRAL INFARCTION   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
CEREBRAL ISCHAEMIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CEREBROVASCULAR ACCIDENT   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
CERVICOBRACHIAL SYNDROME   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
COMA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
CONVULSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DIZZINESS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
2  
ENCEPHALOPATHY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
FACIAL PALSY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HEADACHE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
HEPATIC ENCEPHALOPATHY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYDROCEPHALUS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOAESTHESIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LOSS OF CONSCIOUSNESS   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
MIGRAINE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PARAESTHESIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
QUADRIPARESIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RADICULOPATHY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SPINAL CORD COMPRESSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SUBARACHNOID HAEMORRHAGE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
SYNCOPE   † A
      # participants affected / at risk
      # events
4/2312 (0.17%)
4  
TRANSIENT ISCHAEMIC ATTACK   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
VISUAL FIELD DEFECT   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
3  
Pregnancy, puerperium and perinatal conditions  
FOETAL GROWTH RETARDATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
INTRA-UTERINE DEATH   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RETROPLACENTAL HAEMATOMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Psychiatric disorders  
ACUTE PSYCHOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
AGGRESSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
BIPOLAR DISORDER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CONFUSIONAL STATE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DEPENDENCE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DEPRESSION   † A
      # participants affected / at risk
      # events
10/2312 (0.43%)
10  
HALLUCINATION   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
HALLUCINATION, AUDITORY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HALLUCINATION, VISUAL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HOMICIDAL IDEATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
MOOD SWINGS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PERSECUTORY DELUSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PHOBIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PSYCHOTIC DISORDER   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
SUICIDAL IDEATION   † A
      # participants affected / at risk
      # events
8/2312 (0.35%)
8  
SUICIDE ATTEMPT   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Renal and urinary disorders  
CALCULUS URETERIC   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
CALCULUS URINARY   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DYSURIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
NEPHROLITHIASIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
RENAL COLIC   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RENAL FAILURE   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
RENAL MASS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Reproductive system and breast disorders  
ADENOMYOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
MENORRHAGIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
TESTICULAR NECROSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VARICOCELE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Respiratory, thoracic and mediastinal disorders  
ACUTE RESPIRATORY FAILURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ASTHMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
COUGH   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
DYSPNOEA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
EMPHYSEMA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOXIA   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
LUNG INFILTRATION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PNEUMOTHORAX   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
PRODUCTIVE COUGH   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PULMONARY EMBOLISM   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
RESPIRATORY FAILURE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Skin and subcutaneous tissue disorders  
DECUBITUS ULCER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
ECZEMA ASTEATOTIC   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
INGROWING NAIL   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
SKIN LESION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Social circumstances  
MISCARRIAGE OF PARTNER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
PREGNANCY OF PARTNER   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
Vascular disorders  
DEEP VEIN THROMBOSIS   † A
      # participants affected / at risk
      # events
2/2312 (0.09%)
2  
HAEMATOMA   † A
      # participants affected / at risk
      # events
3/2312 (0.13%)
3  
HAEMORRHAGE   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
HYPOTENSION   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
THROMBOSIS   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VARICOSE VEIN   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
VASCULAR PSEUDOANEURYSM   † A
      # participants affected / at risk
      # events
1/2312 (0.04%)
1  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10.0


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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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 Group )
Study ID Numbers: P02370
Study First Received: June 13, 2002
Results First Received: September 29, 2008
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00039871     History of Changes
Health Authority: United States: Food and Drug Administration





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