Trial Outcomes & Findings for Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569) (NCT NCT00048724)
NCT ID: NCT00048724
Last Updated: 2017-04-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
631 participants
Primary outcome timeframe
Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Results posted on
2017-04-04
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
315
|
|
Overall Study
COMPLETED
|
195
|
197
|
|
Overall Study
NOT COMPLETED
|
116
|
118
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
53
|
12
|
|
Overall Study
Withdrawal by Subject
|
34
|
54
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Protocol-defined Clinical Event
|
17
|
32
|
|
Overall Study
Noncompliance With Protocol
|
4
|
12
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
2
|
2
|
|
Overall Study
Administrative
|
1
|
1
|
Baseline Characteristics
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
Baseline characteristics by cohort
| Measure |
PegIntron
n=311 Participants
PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
|
Untreated Control
n=315 Participants
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=50 years
|
130 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Age, Customized
>50 years
|
181 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical eventPopulation: 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.
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
Outcome measures
| Measure |
PegIntron
n=311 Participants
PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
|
Untreated Control
n=315 Participants
|
|---|---|---|
|
Time to Observation of the First Clinical Event Experienced by a Subject
<=6 Months
|
3 Participants
|
2 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>6 to 12 Months
|
5 Participants
|
5 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>12 to 18 Months
|
4 Participants
|
4 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>18 to 24 Months
|
3 Participants
|
7 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>24 to 30 Months
|
7 Participants
|
6 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>30 to 36 Months
|
1 Participants
|
6 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>36 to 42 Months
|
0 Participants
|
5 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>42 to 48 Months
|
2 Participants
|
0 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>48 to 54 Months
|
2 Participants
|
1 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
>54 to 60 Months
|
0 Participants
|
0 Participants
|
|
Time to Observation of the First Clinical Event Experienced by a Subject
Total Over Study
|
27 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical eventPopulation: 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.
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.
Outcome measures
| Measure |
PegIntron
n=311 Participants
PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
|
Untreated Control
n=315 Participants
|
|---|---|---|
|
Time to Observation of the Disease Progression Experienced by a Subject
<=6 Months
|
16 Participants
|
17 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>6 to 12 Months
|
6 Participants
|
6 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>12 to 18 Months
|
5 Participants
|
7 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>18 to 24 Months
|
12 Participants
|
20 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>24 to 30 Months
|
10 Participants
|
11 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>30 to 36 Months
|
4 Participants
|
9 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>36 to 42 Months
|
2 Participants
|
4 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>42 to 48 Months
|
2 Participants
|
6 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>48 to 54 Months
|
5 Participants
|
4 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
>54 to 60 Months
|
1 Participants
|
3 Participants
|
|
Time to Observation of the Disease Progression Experienced by a Subject
Total Over Study
|
63 Participants
|
87 Participants
|
Adverse Events
PegIntron
Serious events: 93 serious events
Other events: 290 other events
Deaths: 0 deaths
Untreated Control
Serious events: 74 serious events
Other events: 260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron
n=311 participants at risk
|
Untreated Control
n=315 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.3%
4/311 • Number of events 5
|
0.32%
1/315 • Number of events 2
|
|
Blood and lymphatic system disorders
AUTOIMMUNE THROMBOCYTOPENIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Eye disorders
CATARACT NUCLEAR
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Eye disorders
DIABETIC RETINOPATHY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Eye disorders
RETINAL DETACHMENT
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/311
|
0.95%
3/315 • Number of events 3
|
|
Gastrointestinal disorders
ASCITES
|
0.32%
1/311 • Number of events 1
|
0.95%
3/315 • Number of events 3
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
ENTERITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
GASTRIC VARICES HAEMORRHAGE
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.32%
1/311 • Number of events 2
|
0.32%
1/315 • Number of events 2
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.32%
1/311 • Number of events 1
|
0.63%
2/315 • Number of events 2
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
HERNIAL EVENTRATION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
ILEITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.32%
1/311 • Number of events 1
|
0.63%
2/315 • Number of events 2
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/311
|
3.2%
10/315 • Number of events 10
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Gastrointestinal disorders
PERITONITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
RECTAL FISSURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.00%
0/311
|
1.3%
4/315 • Number of events 8
|
|
General disorders
CHEST PAIN
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
General disorders
DEATH
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
General disorders
DISEASE PROGRESSION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
General disorders
MALAISE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
General disorders
OEDEMA PERIPHERAL
|
0.32%
1/311 • Number of events 3
|
0.32%
1/315 • Number of events 1
|
|
General disorders
PYREXIA
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.96%
3/311 • Number of events 3
|
0.95%
3/315 • Number of events 3
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.3%
4/311 • Number of events 4
|
0.00%
0/315
|
|
Hepatobiliary disorders
CHRONIC HEPATIC FAILURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Hepatobiliary disorders
HEPATIC MASS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Hepatobiliary disorders
PORTAL HYPERTENSIVE GASTROPATHY
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
APPENDICITIS
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Infections and infestations
BACTERAEMIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
BRONCHIECTASIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
BRONCHITIS
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
ENDOCARDITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Infections and infestations
FEBRILE INFECTION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
GASTROENTERITIS
|
1.3%
4/311 • Number of events 4
|
0.00%
0/315
|
|
Infections and infestations
HAEMOPHILUS SEPSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
LUNG ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
PILONIDAL CYST
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
PNEUMONIA
|
1.3%
4/311 • Number of events 4
|
0.32%
1/315 • Number of events 1
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
PSOAS ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
PYELONEPHRITIS
|
0.64%
2/311 • Number of events 3
|
0.00%
0/315
|
|
Infections and infestations
RECTAL ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
SEPSIS
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Infections and infestations
SEPTIC SHOCK
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
TOOTH INFECTION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
TUBERCULOSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.64%
2/311 • Number of events 4
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
DISLOCATION OF VERTEBRA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
FALL
|
0.64%
2/311 • Number of events 2
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
INJURY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
NECK INJURY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL FISTULA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE FEVER
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND SECRETION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Investigations
ALPHA 1 FOETOPROTEIN INCREASED
|
0.00%
0/311
|
0.95%
3/315 • Number of events 3
|
|
Investigations
PLATELET COUNT DECREASED
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Investigations
TRANSPLANT EVALUATION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Metabolism and nutrition disorders
DIABETES WITH HYPEROSMOLARITY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
EXTRASKELETAL OSSIFICATION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.96%
3/311 • Number of events 4
|
0.63%
2/315 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
3.5%
11/311 • Number of events 12
|
3.8%
12/315 • Number of events 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PALATE NEOPLASM
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SALIVARY GLAND ADENOMA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
CEREBRAL CYST
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Nervous system disorders
EPILEPSY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
HEADACHE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.64%
2/311 • Number of events 2
|
0.63%
2/315 • Number of events 2
|
|
Nervous system disorders
HYPERTONIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
MENINGORRHAGIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.64%
2/311 • Number of events 3
|
0.00%
0/315
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.96%
3/311 • Number of events 3
|
0.32%
1/315 • Number of events 1
|
|
Psychiatric disorders
BRADYPHRENIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Psychiatric disorders
DELIRIUM
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Psychiatric disorders
DEPRESSION
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Renal and urinary disorders
RENAL COLIC
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.32%
1/311 • Number of events 2
|
0.00%
0/315
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Reproductive system and breast disorders
BREAST CALCIFICATIONS
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.32%
1/311 • Number of events 2
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.96%
3/311 • Number of events 3
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
MIDDLE LOBE SYNDROME
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.64%
2/311 • Number of events 2
|
0.00%
0/315
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.32%
1/311 • Number of events 1
|
0.32%
1/315 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Surgical and medical procedures
POST PROCEDURAL DRAINAGE
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Vascular disorders
FEMORAL ARTERIAL STENOSIS
|
0.00%
0/311
|
0.63%
2/315 • Number of events 2
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Vascular disorders
HYPERTENSION
|
0.64%
2/311 • Number of events 2
|
0.32%
1/315 • Number of events 1
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Vascular disorders
LYMPHOEDEMA
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.32%
1/311 • Number of events 1
|
0.00%
0/315
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/311
|
0.32%
1/315 • Number of events 1
|
Other adverse events
| Measure |
PegIntron
n=311 participants at risk
|
Untreated Control
n=315 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.4%
20/311 • Number of events 31
|
2.5%
8/315 • Number of events 9
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
13.8%
43/311 • Number of events 119
|
5.7%
18/315 • Number of events 26
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
19.3%
60/311 • Number of events 69
|
17.1%
54/315 • Number of events 61
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
52/311 • Number of events 122
|
6.3%
20/315 • Number of events 41
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.6%
33/311 • Number of events 40
|
6.7%
21/315 • Number of events 27
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.5%
45/311 • Number of events 66
|
14.6%
46/315 • Number of events 67
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.1%
16/311 • Number of events 20
|
4.4%
14/315 • Number of events 17
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.9%
37/311 • Number of events 57
|
7.9%
25/315 • Number of events 30
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.4%
20/311 • Number of events 27
|
6.7%
21/315 • Number of events 29
|
|
Gastrointestinal disorders
GASTRITIS
|
6.4%
20/311 • Number of events 22
|
12.7%
40/315 • Number of events 42
|
|
Gastrointestinal disorders
NAUSEA
|
15.8%
49/311 • Number of events 62
|
12.4%
39/315 • Number of events 58
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
11.3%
35/311 • Number of events 41
|
16.5%
52/315 • Number of events 56
|
|
Gastrointestinal disorders
VOMITING
|
5.8%
18/311 • Number of events 21
|
3.5%
11/315 • Number of events 11
|
|
General disorders
ASTHENIA
|
14.5%
45/311 • Number of events 70
|
11.7%
37/315 • Number of events 48
|
|
General disorders
CHILLS
|
8.4%
26/311 • Number of events 37
|
0.95%
3/315 • Number of events 4
|
|
General disorders
FATIGUE
|
33.1%
103/311 • Number of events 152
|
24.8%
78/315 • Number of events 92
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
14.8%
46/311 • Number of events 61
|
1.3%
4/315 • Number of events 4
|
|
General disorders
INJECTION SITE ERYTHEMA
|
11.6%
36/311 • Number of events 37
|
0.00%
0/315
|
|
General disorders
IRRITABILITY
|
13.2%
41/311 • Number of events 48
|
5.4%
17/315 • Number of events 18
|
|
General disorders
MALAISE
|
5.1%
16/311 • Number of events 41
|
3.5%
11/315 • Number of events 13
|
|
General disorders
OEDEMA PERIPHERAL
|
6.1%
19/311 • Number of events 23
|
9.2%
29/315 • Number of events 39
|
|
General disorders
PYREXIA
|
18.3%
57/311 • Number of events 163
|
4.4%
14/315 • Number of events 15
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
14.5%
45/311 • Number of events 61
|
16.2%
51/315 • Number of events 62
|
|
Infections and infestations
BRONCHITIS
|
6.4%
20/311 • Number of events 28
|
7.3%
23/315 • Number of events 38
|
|
Infections and infestations
INFLUENZA
|
5.1%
16/311 • Number of events 18
|
8.9%
28/315 • Number of events 37
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
20/311 • Number of events 27
|
7.9%
25/315 • Number of events 36
|
|
Infections and infestations
SINUSITIS
|
5.5%
17/311 • Number of events 23
|
5.4%
17/315 • Number of events 20
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
9/311 • Number of events 20
|
5.1%
16/315 • Number of events 22
|
|
Metabolism and nutrition disorders
ANOREXIA
|
8.0%
25/311 • Number of events 32
|
2.5%
8/315 • Number of events 10
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.8%
21/311 • Number of events 27
|
1.6%
5/315 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
21.9%
68/311 • Number of events 120
|
20.0%
63/315 • Number of events 90
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.1%
44/311 • Number of events 47
|
12.4%
39/315 • Number of events 51
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.3%
29/311 • Number of events 38
|
5.4%
17/315 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
24.4%
76/311 • Number of events 242
|
6.0%
19/315 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.4%
23/311 • Number of events 36
|
4.1%
13/315 • Number of events 14
|
|
Nervous system disorders
DIZZINESS
|
7.1%
22/311 • Number of events 32
|
6.3%
20/315 • Number of events 23
|
|
Nervous system disorders
HEADACHE
|
33.1%
103/311 • Number of events 249
|
14.9%
47/315 • Number of events 62
|
|
Psychiatric disorders
ANXIETY
|
7.7%
24/311 • Number of events 46
|
5.1%
16/315 • Number of events 19
|
|
Psychiatric disorders
DEPRESSION
|
11.3%
35/311 • Number of events 41
|
8.3%
26/315 • Number of events 35
|
|
Psychiatric disorders
INSOMNIA
|
16.1%
50/311 • Number of events 77
|
14.3%
45/315 • Number of events 55
|
|
Renal and urinary disorders
RENAL CYST
|
1.9%
6/311 • Number of events 7
|
6.0%
19/315 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.6%
33/311 • Number of events 46
|
10.8%
34/315 • Number of events 46
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.5%
17/311 • Number of events 22
|
4.4%
14/315 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
7.4%
23/311 • Number of events 30
|
2.9%
9/315 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
11.6%
36/311 • Number of events 41
|
8.6%
27/315 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.5%
42/311 • Number of events 64
|
8.6%
27/315 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.0%
31/311 • Number of events 41
|
3.2%
10/315 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
SPIDER NAEVUS
|
4.5%
14/311 • Number of events 16
|
5.4%
17/315 • Number of events 19
|
|
Vascular disorders
HYPERTENSION
|
13.2%
41/311 • Number of events 47
|
12.1%
38/315 • Number of events 40
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER