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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

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ClinicalTrials.gov Identifier: NCT00048724
Recruitment Status : Completed
First Posted : November 8, 2002
Results First Posted : June 11, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Cirrhosis
Intervention Biological: peginterferon alfa-2b (SCH 54031)
Enrollment 631

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title PegIntron Untreated Control
Hide Arm/Group Description PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up [Not Specified]
Period Title: Overall Study
Started 311 315
Completed 195 197
Not Completed 116 118
Reason Not Completed
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
Arm/Group Title PegIntron Untreated Control Total
Hide Arm/Group Description PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 311 315 626
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 participants
<=50 years 130 132 262
>50 years 181 183 364
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 participants
Female
105
  33.8%
100
  31.7%
205
  32.7%
Male
206
  66.2%
215
  68.3%
421
  67.3%
1.Primary Outcome
Title Time to Observation of the First Clinical Event Experienced by a Subject
Hide Description Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation
Time Frame Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population is modified intent to treat (MITT), comprising all 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 efficacy analyses.
Arm/Group Title PegIntron Untreated Control
Hide Arm/Group Description:
PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
[Not Specified]
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: Participants
<=6 Months 3 2
>6 to 12 Months 5 5
>12 to 18 Months 4 4
>18 to 24 Months 3 7
>24 to 30 Months 7 6
>30 to 36 Months 1 6
>36 to 42 Months 0 5
>42 to 48 Months 2 0
>48 to 54 Months 2 1
>54 to 60 Months 0 0
Total Over Study 27 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PegIntron, Untreated Control
Comments The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1439
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Age (<= 50 years, >50 years) and participation in a prior study (yes, no) were stratification factors.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.452
Confidence Interval 95%
0.880 to 2.396
Estimation Comments Hazard ratio represents results of untreated control relative to treatment.
2.Secondary Outcome
Title Time to Observation of the Disease Progression Experienced by a Subject
Hide Description Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.
Time Frame Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population is modified intent to treat (MITT), comprising all 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 efficacy analyses.
Arm/Group Title PegIntron Untreated Control
Hide Arm/Group Description:
PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
[Not Specified]
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: Participants
<=6 Months 16 17
>6 to 12 Months 6 6
>12 to 18 Months 5 7
>18 to 24 Months 12 20
>24 to 30 Months 10 11
>30 to 36 Months 4 9
>36 to 42 Months 2 4
>42 to 48 Months 2 6
>48 to 54 Months 5 4
>54 to 60 Months 1 3
Total Over Study 63 87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PegIntron, Untreated Control
Comments The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Age (<= 50 years, >50 years) and participation in a prior study (yes, no) were stratification factors.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.564
Confidence Interval 95%
1.130 to 2.166
Estimation Comments Hazard ratio represents results of untreated control relative to treatment.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PegIntron Untreated Control
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
PegIntron Untreated Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PegIntron Untreated Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/311 (29.90%)      74/315 (23.49%)    
Blood and lymphatic system disorders     
ANAEMIA  1  4/311 (1.29%)  5 1/315 (0.32%)  2
AUTOIMMUNE THROMBOCYTOPENIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
FEBRILE NEUTROPENIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
THROMBOCYTOPENIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ANGINA PECTORIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ARRHYTHMIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CARDIAC FAILURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CORONARY ARTERY DISEASE  1  1/311 (0.32%)  1 1/315 (0.32%)  1
MITRAL VALVE INCOMPETENCE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
MYOCARDIAL INFARCTION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Ear and labyrinth disorders     
HEARING IMPAIRED  1  0/311 (0.00%)  0 1/315 (0.32%)  1
TINNITUS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
VERTIGO  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Eye disorders     
CATARACT NUCLEAR  1  1/311 (0.32%)  1 0/315 (0.00%)  0
DIABETIC RETINOPATHY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
RETINAL DETACHMENT  1  1/311 (0.32%)  1 0/315 (0.00%)  0
VITREOUS HAEMORRHAGE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ABDOMINAL PAIN LOWER  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ABDOMINAL PAIN UPPER  1  0/311 (0.00%)  0 3/315 (0.95%)  3
ASCITES  1  1/311 (0.32%)  1 3/315 (0.95%)  3
CONSTIPATION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
DIARRHOEA  1  1/311 (0.32%)  1 1/315 (0.32%)  1
ENTERITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
GASTRIC ULCER HAEMORRHAGE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
GASTRIC VARICES HAEMORRHAGE  1  0/311 (0.00%)  0 2/315 (0.63%)  2
GASTRITIS EROSIVE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  1/311 (0.32%)  2 1/315 (0.32%)  2
GINGIVAL BLEEDING  1  1/311 (0.32%)  1 1/315 (0.32%)  1
HAEMATEMESIS  1  1/311 (0.32%)  1 2/315 (0.63%)  2
HAEMORRHOIDS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HERNIAL EVENTRATION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ILEITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
INGUINAL HERNIA  1  1/311 (0.32%)  1 1/315 (0.32%)  1
INTESTINAL OBSTRUCTION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MALLORY-WEISS SYNDROME  1  0/311 (0.00%)  0 1/315 (0.32%)  1
MELAENA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
NAUSEA  1  1/311 (0.32%)  1 2/315 (0.63%)  2
OESOPHAGEAL ULCER  1  0/311 (0.00%)  0 1/315 (0.32%)  1
OESOPHAGEAL VARICES HAEMORRHAGE  1  0/311 (0.00%)  0 10/315 (3.17%)  10
PANCREATITIS ACUTE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
PERITONITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
RECTAL FISSURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
UMBILICAL HERNIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
VARICES OESOPHAGEAL  1  0/311 (0.00%)  0 4/315 (1.27%)  8
General disorders     
CHEST PAIN  1  2/311 (0.64%)  2 0/315 (0.00%)  0
DEATH  1  0/311 (0.00%)  0 1/315 (0.32%)  1
DISEASE PROGRESSION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
INFLUENZA LIKE ILLNESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MALAISE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MULTI-ORGAN FAILURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  1/311 (0.32%)  1 0/315 (0.00%)  0
OEDEMA PERIPHERAL  1  1/311 (0.32%)  3 1/315 (0.32%)  1
PYREXIA  1  1/311 (0.32%)  1 1/315 (0.32%)  1
Hepatobiliary disorders     
BILIARY COLIC  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CHOLECYSTITIS  1  3/311 (0.96%)  3 3/315 (0.95%)  3
CHOLECYSTITIS ACUTE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CHOLELITHIASIS  1  4/311 (1.29%)  4 0/315 (0.00%)  0
CHRONIC HEPATIC FAILURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
HEPATIC CIRRHOSIS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
HEPATIC FAILURE  1  0/311 (0.00%)  0 2/315 (0.63%)  2
HEPATIC MASS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
JAUNDICE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
LIVER DISORDER  1  2/311 (0.64%)  2 0/315 (0.00%)  0
PORTAL HYPERTENSIVE GASTROPATHY  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Infections and infestations     
ABDOMINAL WALL ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
APPENDICITIS  1  2/311 (0.64%)  2 0/315 (0.00%)  0
BACTERAEMIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
BRONCHIECTASIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
BRONCHITIS  1  1/311 (0.32%)  1 1/315 (0.32%)  1
CELLULITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ENDOCARDITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ENDOCARDITIS BACTERIAL  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
FEBRILE INFECTION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
GASTROENTERITIS  1  4/311 (1.29%)  4 0/315 (0.00%)  0
HAEMOPHILUS SEPSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
INTERVERTEBRAL DISCITIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
LUNG ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MENINGITIS VIRAL  1  1/311 (0.32%)  1 0/315 (0.00%)  0
OESOPHAGEAL CANDIDIASIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PILONIDAL CYST  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PNEUMONIA  1  4/311 (1.29%)  4 1/315 (0.32%)  1
POSTOPERATIVE WOUND INFECTION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PSOAS ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PYELONEPHRITIS  1  2/311 (0.64%)  3 0/315 (0.00%)  0
RECTAL ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
SEPSIS  1  1/311 (0.32%)  1 1/315 (0.32%)  1
SEPTIC SHOCK  1  1/311 (0.32%)  1 0/315 (0.00%)  0
SUBCUTANEOUS ABSCESS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
TOOTH INFECTION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
TUBERCULOSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
URINARY TRACT INFECTION  1  2/311 (0.64%)  2 0/315 (0.00%)  0
Injury, poisoning and procedural complications     
ANKLE FRACTURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
CERVICAL VERTEBRAL FRACTURE  1  2/311 (0.64%)  4 0/315 (0.00%)  0
CONCUSSION  1  1/311 (0.32%)  1 1/315 (0.32%)  1
DISLOCATION OF VERTEBRA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
FALL  1  2/311 (0.64%)  2 1/315 (0.32%)  1
FIBULA FRACTURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
FOOT FRACTURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HEAD INJURY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
INJURY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
LUMBAR VERTEBRAL FRACTURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MENISCUS LESION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
NECK INJURY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
OVERDOSE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
POST PROCEDURAL FISTULA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
POSTOPERATIVE FEVER  1  1/311 (0.32%)  1 0/315 (0.00%)  0
RIB FRACTURE  1  1/311 (0.32%)  1 1/315 (0.32%)  1
SKIN LACERATION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
SKULL FRACTURE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
THERMAL BURN  1  1/311 (0.32%)  1 0/315 (0.00%)  0
TIBIA FRACTURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
WOUND SECRETION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
WRIST FRACTURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Investigations     
ALPHA 1 FOETOPROTEIN INCREASED  1  0/311 (0.00%)  0 3/315 (0.95%)  3
PLATELET COUNT DECREASED  1  1/311 (0.32%)  1 0/315 (0.00%)  0
TRANSPLANT EVALUATION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Metabolism and nutrition disorders     
ANOREXIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
DEHYDRATION  1  2/311 (0.64%)  2 0/315 (0.00%)  0
DIABETES MELLITUS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
DIABETES MELLITUS INADEQUATE CONTROL  1  0/311 (0.00%)  0 2/315 (0.63%)  2
DIABETES WITH HYPEROSMOLARITY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HYPOMAGNESAEMIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
TYPE 2 DIABETES MELLITUS  1  1/311 (0.32%)  1 1/315 (0.32%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
BACK PAIN  1  1/311 (0.32%)  1 1/315 (0.32%)  1
EXTRASKELETAL OSSIFICATION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
FOOT DEFORMITY  1  0/311 (0.00%)  0 1/315 (0.32%)  1
INTERVERTEBRAL DISC PROTRUSION  1  1/311 (0.32%)  1 1/315 (0.32%)  1
LUMBAR SPINAL STENOSIS  1  2/311 (0.64%)  2 0/315 (0.00%)  0
NECK PAIN  1  1/311 (0.32%)  1 0/315 (0.00%)  0
OSTEOARTHRITIS  1  1/311 (0.32%)  1 1/315 (0.32%)  1
OSTEONECROSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
SYSTEMIC LUPUS ERYTHEMATOSUS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  1/311 (0.32%)  1 1/315 (0.32%)  1
BREAST CANCER  1  1/311 (0.32%)  1 1/315 (0.32%)  1
BREAST CANCER METASTATIC  1  1/311 (0.32%)  1 0/315 (0.00%)  0
COLON CANCER  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HEPATIC NEOPLASM  1  3/311 (0.96%)  4 2/315 (0.63%)  2
HEPATIC NEOPLASM MALIGNANT  1  11/311 (3.54%)  12 12/315 (3.81%)  12
LYMPHOMA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
MALIGNANT MELANOMA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
MALIGNANT PALATE NEOPLASM  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MULTIPLE MYELOMA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
OROPHARYNGEAL CANCER STAGE UNSPECIFIED  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PROSTATE CANCER  1  0/311 (0.00%)  0 2/315 (0.63%)  2
RECTAL CANCER  1  0/311 (0.00%)  0 1/315 (0.32%)  1
SALIVARY GLAND ADENOMA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
UTERINE LEIOMYOMA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Nervous system disorders     
CARPAL TUNNEL SYNDROME  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CEREBRAL CYST  1  1/311 (0.32%)  1 0/315 (0.00%)  0
CEREBRAL INFARCTION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
CEREBROVASCULAR ACCIDENT  1  1/311 (0.32%)  1 1/315 (0.32%)  1
CONVULSION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
ENCEPHALOPATHY  1  0/311 (0.00%)  0 2/315 (0.63%)  2
EPILEPSY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HEADACHE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
HEPATIC ENCEPHALOPATHY  1  2/311 (0.64%)  2 2/315 (0.63%)  2
HYPERTONIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
INTRACRANIAL ANEURYSM  1  0/311 (0.00%)  0 1/315 (0.32%)  1
LOSS OF CONSCIOUSNESS  1  1/311 (0.32%)  1 1/315 (0.32%)  1
MENINGORRHAGIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
SUBARACHNOID HAEMORRHAGE  1  1/311 (0.32%)  1 1/315 (0.32%)  1
SYNCOPE  1  2/311 (0.64%)  3 0/315 (0.00%)  0
Psychiatric disorders     
ALCOHOL ABUSE  1  3/311 (0.96%)  3 1/315 (0.32%)  1
BRADYPHRENIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
DELIRIUM  1  1/311 (0.32%)  1 0/315 (0.00%)  0
DEPRESSION  1  1/311 (0.32%)  1 0/315 (0.00%)  0
SUICIDAL IDEATION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Renal and urinary disorders     
CALCULUS URINARY  1  1/311 (0.32%)  1 0/315 (0.00%)  0
NEPHROLITHIASIS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
RENAL COLIC  1  1/311 (0.32%)  1 0/315 (0.00%)  0
RENAL FAILURE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
URINARY RETENTION  1  1/311 (0.32%)  2 0/315 (0.00%)  0
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
BREAST CALCIFICATIONS  1  2/311 (0.64%)  2 0/315 (0.00%)  0
CYSTOCELE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MENORRHAGIA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
OVARIAN CYST  1  0/311 (0.00%)  0 1/315 (0.32%)  1
UTERINE HAEMORRHAGE  1  0/311 (0.00%)  0 1/315 (0.32%)  1
UTERINE PROLAPSE  1  2/311 (0.64%)  2 0/315 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/311 (0.32%)  2 0/315 (0.00%)  0
DYSPNOEA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
HAEMOPTYSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
INTERSTITIAL LUNG DISEASE  1  3/311 (0.96%)  3 0/315 (0.00%)  0
LUNG DISORDER  1  1/311 (0.32%)  1 0/315 (0.00%)  0
MIDDLE LOBE SYNDROME  1  0/311 (0.00%)  0 1/315 (0.32%)  1
PLEURAL EFFUSION  1  0/311 (0.00%)  0 1/315 (0.32%)  1
PULMONARY HYPERTENSION  1  2/311 (0.64%)  2 0/315 (0.00%)  0
RESPIRATORY FAILURE  1  1/311 (0.32%)  1 1/315 (0.32%)  1
SLEEP APNOEA SYNDROME  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Skin and subcutaneous tissue disorders     
RASH  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Surgical and medical procedures     
POST PROCEDURAL DRAINAGE  1  1/311 (0.32%)  1 0/315 (0.00%)  0
Vascular disorders     
ARTERIOSCLEROSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
FEMORAL ARTERIAL STENOSIS  1  0/311 (0.00%)  0 2/315 (0.63%)  2
HAEMATOMA  1  0/311 (0.00%)  0 1/315 (0.32%)  1
HYPERTENSION  1  2/311 (0.64%)  2 1/315 (0.32%)  1
ILIAC ARTERY STENOSIS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
LYMPHOEDEMA  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PELVIC VENOUS THROMBOSIS  1  1/311 (0.32%)  1 0/315 (0.00%)  0
PERIPHERAL VASCULAR DISORDER  1  0/311 (0.00%)  0 1/315 (0.32%)  1
VARICOSE VEIN  1  0/311 (0.00%)  0 1/315 (0.32%)  1
VASCULITIS  1  0/311 (0.00%)  0 1/315 (0.32%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIntron Untreated Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   290/311 (93.25%)      260/315 (82.54%)    
Blood and lymphatic system disorders     
LEUKOPENIA  1  20/311 (6.43%)  31 8/315 (2.54%)  9
NEUTROPENIA  1  43/311 (13.83%)  119 18/315 (5.71%)  26
SPLENOMEGALY  1  60/311 (19.29%)  69 54/315 (17.14%)  61
THROMBOCYTOPENIA  1  52/311 (16.72%)  122 20/315 (6.35%)  41
Gastrointestinal disorders     
ABDOMINAL PAIN  1  33/311 (10.61%)  40 21/315 (6.67%)  27
ABDOMINAL PAIN UPPER  1  45/311 (14.47%)  66 46/315 (14.60%)  67
CONSTIPATION  1  16/311 (5.14%)  20 14/315 (4.44%)  17
DIARRHOEA  1  37/311 (11.90%)  57 25/315 (7.94%)  30
DYSPEPSIA  1  20/311 (6.43%)  27 21/315 (6.67%)  29
GASTRITIS  1  20/311 (6.43%)  22 40/315 (12.70%)  42
NAUSEA  1  49/311 (15.76%)  62 39/315 (12.38%)  58
VARICES OESOPHAGEAL  1  35/311 (11.25%)  41 52/315 (16.51%)  56
VOMITING  1  18/311 (5.79%)  21 11/315 (3.49%)  11
General disorders     
ASTHENIA  1  45/311 (14.47%)  70 37/315 (11.75%)  48
CHILLS  1  26/311 (8.36%)  37 3/315 (0.95%)  4
FATIGUE  1  103/311 (33.12%)  152 78/315 (24.76%)  92
INFLUENZA LIKE ILLNESS  1  46/311 (14.79%)  61 4/315 (1.27%)  4
INJECTION SITE ERYTHEMA  1  36/311 (11.58%)  37 0/315 (0.00%)  0
IRRITABILITY  1  41/311 (13.18%)  48 17/315 (5.40%)  18
MALAISE  1  16/311 (5.14%)  41 11/315 (3.49%)  13
OEDEMA PERIPHERAL  1  19/311 (6.11%)  23 29/315 (9.21%)  39
PYREXIA  1  57/311 (18.33%)  163 14/315 (4.44%)  15
Hepatobiliary disorders     
HEPATOMEGALY  1  45/311 (14.47%)  61 51/315 (16.19%)  62
Infections and infestations     
BRONCHITIS  1  20/311 (6.43%)  28 23/315 (7.30%)  38
INFLUENZA  1  16/311 (5.14%)  18 28/315 (8.89%)  37
NASOPHARYNGITIS  1  20/311 (6.43%)  27 25/315 (7.94%)  36
SINUSITIS  1  17/311 (5.47%)  23 17/315 (5.40%)  20
URINARY TRACT INFECTION  1  9/311 (2.89%)  20 16/315 (5.08%)  22
Metabolism and nutrition disorders     
ANOREXIA  1  25/311 (8.04%)  32 8/315 (2.54%)  10
DECREASED APPETITE  1  21/311 (6.75%)  27 5/315 (1.59%)  5
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  68/311 (21.86%)  120 63/315 (20.00%)  90
BACK PAIN  1  44/311 (14.15%)  47 39/315 (12.38%)  51
MUSCLE SPASMS  1  29/311 (9.32%)  38 17/315 (5.40%)  19
MYALGIA  1  76/311 (24.44%)  242 19/315 (6.03%)  22
PAIN IN EXTREMITY  1  23/311 (7.40%)  36 13/315 (4.13%)  14
Nervous system disorders     
DIZZINESS  1  22/311 (7.07%)  32 20/315 (6.35%)  23
HEADACHE  1  103/311 (33.12%)  249 47/315 (14.92%)  62
Psychiatric disorders     
ANXIETY  1  24/311 (7.72%)  46 16/315 (5.08%)  19
DEPRESSION  1  35/311 (11.25%)  41 26/315 (8.25%)  35
INSOMNIA  1  50/311 (16.08%)  77 45/315 (14.29%)  55
Renal and urinary disorders     
RENAL CYST  1  6/311 (1.93%)  7 19/315 (6.03%)  19
Respiratory, thoracic and mediastinal disorders     
COUGH  1  33/311 (10.61%)  46 34/315 (10.79%)  46
DYSPNOEA  1  17/311 (5.47%)  22 14/315 (4.44%)  15
EPISTAXIS  1  23/311 (7.40%)  30 9/315 (2.86%)  9
Skin and subcutaneous tissue disorders     
ALOPECIA  1  36/311 (11.58%)  41 27/315 (8.57%)  30
PRURITUS  1  42/311 (13.50%)  64 27/315 (8.57%)  38
RASH  1  31/311 (9.97%)  41 10/315 (3.17%)  14
SPIDER NAEVUS  1  14/311 (4.50%)  16 17/315 (5.40%)  19
Vascular disorders     
HYPERTENSION  1  41/311 (13.18%)  47 38/315 (12.06%)  40
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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 investigator agrees to provide review copies to the sponsor 30 days prior to submission for publication or presentation. The sponsor shall have editorial rights and the right to review and comment on the data analysis and presentation. If the parties disagree, investigator agrees to meet with the sponsor's representatives for the purpose of making good faith efforts to discuss and resolve any such issues.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00048724     History of Changes
Other Study ID Numbers: P02569
First Submitted: November 6, 2002
First Posted: November 8, 2002
Results First Submitted: April 23, 2009
Results First Posted: June 11, 2009
Last Update Posted: April 4, 2017