Trial Outcomes & Findings for PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370) (NCT NCT00039871)
NCT ID: NCT00039871
Last Updated: 2017-04-04
Results Overview
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2333 participants
Primary outcome timeframe
Assessed at end of 24 weeks posttreatment follow-up
Results posted on
2017-04-04
Participant Flow
Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.
Participant milestones
| Measure |
PegIntron Plus Rebetol
|
|---|---|
|
Overall Study
STARTED
|
2312
|
|
Overall Study
COMPLETED
|
928
|
|
Overall Study
NOT COMPLETED
|
1384
|
Reasons for withdrawal
| Measure |
PegIntron Plus Rebetol
|
|---|---|
|
Overall Study
Adverse Event
|
165
|
|
Overall Study
Lost to Follow-up
|
18
|
|
Overall Study
Protocol Violation
|
24
|
|
Overall Study
Withdrawal by Subject
|
97
|
|
Overall Study
Did not meet eligibility criteria
|
11
|
|
Overall Study
Administrative
|
1
|
|
Overall Study
Discontinued at Week 12 per protocol
|
1061
|
|
Overall Study
Never entered follow-up
|
7
|
Baseline Characteristics
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
Baseline characteristics by cohort
| Measure |
PegIntron Plus Rebetol
n=2312 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2267 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=99 Participants
|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
662 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1650 Participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Genotype 1
|
1859 number of participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Genotype 2
|
75 number of participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Genotype 3
|
293 number of participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Genotype 4
|
68 number of participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Nontypable
|
8 number of participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) Genotype
Missing
|
9 number of participants
n=99 Participants
|
|
METAVIR Fibrosis score
F1
|
2 number of participants
n=99 Participants
|
|
METAVIR Fibrosis score
F2
|
658 number of participants
n=99 Participants
|
|
METAVIR Fibrosis score
F3
|
676 number of participants
n=99 Participants
|
|
METAVIR Fibrosis score
F4
|
974 number of participants
n=99 Participants
|
|
METAVIR Fibrosis score
Missing
|
2 number of participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed at end of 24 weeks posttreatment follow-upPopulation: Participants who received at least one dose of study medication
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Outcome measures
| Measure |
PegIntron Plus Rebetol
n=2293 Participants
|
|---|---|
|
Sustained Virologic Response (SVR) Rate
|
497 Participants
|
SECONDARY outcome
Timeframe: 24 weeks posttreatmentPopulation: Participants who had undetectable HCV-RNA at Treatment Week 12
Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Outcome measures
| Measure |
PegIntron Plus Rebetol
n=823 Participants
|
|---|---|
|
Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
|
463 Participants
|
SECONDARY outcome
Timeframe: 24 weeks posttreatmentPopulation: Participants with detectable but \>=2 log drop in HCV-RNA at Treatment Week 12
Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Outcome measures
| Measure |
PegIntron Plus Rebetol
n=188 Participants
|
|---|---|
|
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
|
23 Participants
|
Adverse Events
PegIntron Plus Rebetol
Serious events: 200 serious events
Other events: 2201 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron Plus Rebetol
n=2312 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.17%
4/2312 • Number of events 4
|
|
Blood and lymphatic system disorders
AUTOIMMUNE THROMBOCYTOPENIA
|
0.04%
1/2312 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.13%
3/2312 • Number of events 3
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY MEDIASTINAL
|
0.04%
1/2312 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.30%
7/2312 • Number of events 9
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.09%
2/2312 • Number of events 2
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.09%
2/2312 • Number of events 2
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.17%
4/2312 • Number of events 4
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
CARDIAC ARREST
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.09%
2/2312 • Number of events 2
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.09%
2/2312 • Number of events 2
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.04%
1/2312 • Number of events 1
|
|
Cardiac disorders
POSTINFARCTION ANGINA
|
0.04%
1/2312 • Number of events 1
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.04%
1/2312 • Number of events 1
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.04%
1/2312 • Number of events 1
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.09%
2/2312 • Number of events 2
|
|
Ear and labyrinth disorders
MENIERE'S DISEASE
|
0.04%
1/2312 • Number of events 1
|
|
Endocrine disorders
ADRENAL MASS
|
0.04%
1/2312 • Number of events 1
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.04%
1/2312 • Number of events 1
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.04%
1/2312 • Number of events 1
|
|
Eye disorders
CATARACT
|
0.09%
2/2312 • Number of events 4
|
|
Eye disorders
EYE INFLAMMATION
|
0.04%
1/2312 • Number of events 1
|
|
Eye disorders
GLAUCOMA
|
0.04%
1/2312 • Number of events 1
|
|
Eye disorders
RETINAL ARTERY STENOSIS
|
0.04%
1/2312 • Number of events 2
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.04%
1/2312 • Number of events 1
|
|
Eye disorders
VISION BLURRED
|
0.09%
2/2312 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.13%
3/2312 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.04%
1/2312 • Number of events 2
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
APPENDICITIS PERFORATED
|
0.04%
1/2312 • Number of events 2
|
|
Gastrointestinal disorders
ASCITES
|
0.09%
2/2312 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.13%
3/2312 • Number of events 3
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
EROSIVE DUODENITIS
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.09%
2/2312 • Number of events 2
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.09%
2/2312 • Number of events 2
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.17%
4/2312 • Number of events 4
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.09%
2/2312 • Number of events 2
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.04%
1/2312 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.13%
3/2312 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING PROJECTILE
|
0.04%
1/2312 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.13%
3/2312 • Number of events 3
|
|
General disorders
CHEST PAIN
|
0.35%
8/2312 • Number of events 8
|
|
General disorders
DISEASE PROGRESSION
|
0.09%
2/2312 • Number of events 2
|
|
General disorders
FATIGUE
|
0.09%
2/2312 • Number of events 2
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.09%
2/2312 • Number of events 2
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.04%
1/2312 • Number of events 1
|
|
General disorders
PYREXIA
|
0.17%
4/2312 • Number of events 4
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.09%
2/2312 • Number of events 2
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.17%
4/2312 • Number of events 4
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.17%
4/2312 • Number of events 4
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.04%
1/2312 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.04%
1/2312 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.04%
1/2312 • Number of events 1
|
|
Hepatobiliary disorders
HEPATORENAL SYNDROME
|
0.04%
1/2312 • Number of events 1
|
|
Hepatobiliary disorders
HYDROCHOLECYSTIS
|
0.04%
1/2312 • Number of events 1
|
|
Hepatobiliary disorders
JAUNDICE
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.26%
6/2312 • Number of events 6
|
|
Infections and infestations
BACTERAEMIA
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
BOUTONNEUSE FEVER
|
0.09%
2/2312 • Number of events 2
|
|
Infections and infestations
BRONCHITIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.30%
7/2312 • Number of events 7
|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
CERVICITIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
DIVERTICULITIS
|
0.09%
2/2312 • Number of events 3
|
|
Infections and infestations
ERYSIPELAS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
FURUNCLE
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.17%
4/2312 • Number of events 4
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.09%
2/2312 • Number of events 2
|
|
Infections and infestations
LEPROSY
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.09%
2/2312 • Number of events 2
|
|
Infections and infestations
LUNG ABSCESS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
LUNG INFECTION
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
OTITIS MEDIA
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.09%
2/2312 • Number of events 3
|
|
Infections and infestations
PNEUMONIA
|
0.43%
10/2312 • Number of events 10
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
PYELONEPHRITIS
|
0.09%
2/2312 • Number of events 2
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.09%
2/2312 • Number of events 2
|
|
Infections and infestations
RENAL ABSCESS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
SEPTIC SHOCK
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
STAPHYLOCOCCAL ABSCESS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
SUPERINFECTION
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.04%
1/2312 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
ACCIDENT AT WORK
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
EXTRADURAL HAEMATOMA
|
0.09%
2/2312 • Number of events 2
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
0.13%
3/2312 • Number of events 3
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
FOREIGN BODY TRAUMA
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.09%
2/2312 • Number of events 2
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
INJURY
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.09%
2/2312 • Number of events 2
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.09%
2/2312 • Number of events 2
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.09%
2/2312 • Number of events 3
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.26%
6/2312 • Number of events 6
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.09%
2/2312 • Number of events 3
|
|
Injury, poisoning and procedural complications
STENT OCCLUSION
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.04%
1/2312 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.04%
1/2312 • Number of events 1
|
|
Investigations
BLOOD PRESSURE ORTHOSTATIC
|
0.04%
1/2312 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.13%
3/2312 • Number of events 4
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.04%
1/2312 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.13%
3/2312 • Number of events 3
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INSULIN-DEPENDENT
|
0.04%
1/2312 • Number of events 2
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.04%
1/2312 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.04%
1/2312 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.09%
2/2312 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.04%
1/2312 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.04%
1/2312 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILIARY ADENOMA
|
0.04%
1/2312 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.09%
2/2312 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.26%
6/2312 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.09%
2/2312 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA STAGE UNSPECIFIED
|
0.04%
1/2312 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.04%
1/2312 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.04%
1/2312 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.09%
2/2312 • Number of events 2
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.09%
2/2312 • Number of events 2
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
COMA
|
0.13%
3/2312 • Number of events 3
|
|
Nervous system disorders
CONVULSION
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
0.04%
1/2312 • Number of events 2
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
FACIAL PALSY
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
0.09%
2/2312 • Number of events 2
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.13%
3/2312 • Number of events 3
|
|
Nervous system disorders
MIGRAINE
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
PARAESTHESIA
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
QUADRIPARESIS
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
RADICULOPATHY
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.04%
1/2312 • Number of events 1
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.09%
2/2312 • Number of events 2
|
|
Nervous system disorders
SYNCOPE
|
0.17%
4/2312 • Number of events 4
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.09%
2/2312 • Number of events 3
|
|
Nervous system disorders
VISUAL FIELD DEFECT
|
0.09%
2/2312 • Number of events 3
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL GROWTH RETARDATION
|
0.04%
1/2312 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
INTRA-UTERINE DEATH
|
0.04%
1/2312 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
RETROPLACENTAL HAEMATOMA
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
AGGRESSION
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
DEPENDENCE
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
0.43%
10/2312 • Number of events 10
|
|
Psychiatric disorders
HALLUCINATION
|
0.13%
3/2312 • Number of events 3
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
HOMICIDAL IDEATION
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
MOOD SWINGS
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
PERSECUTORY DELUSION
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
PHOBIA
|
0.04%
1/2312 • Number of events 1
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.13%
3/2312 • Number of events 3
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.35%
8/2312 • Number of events 8
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.04%
1/2312 • Number of events 1
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.04%
1/2312 • Number of events 1
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.04%
1/2312 • Number of events 1
|
|
Renal and urinary disorders
DYSURIA
|
0.04%
1/2312 • Number of events 1
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.09%
2/2312 • Number of events 2
|
|
Renal and urinary disorders
RENAL COLIC
|
0.04%
1/2312 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.09%
2/2312 • Number of events 2
|
|
Renal and urinary disorders
RENAL MASS
|
0.04%
1/2312 • Number of events 1
|
|
Reproductive system and breast disorders
ADENOMYOSIS
|
0.04%
1/2312 • Number of events 1
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.04%
1/2312 • Number of events 1
|
|
Reproductive system and breast disorders
TESTICULAR NECROSIS
|
0.04%
1/2312 • Number of events 1
|
|
Reproductive system and breast disorders
VARICOCELE
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.13%
3/2312 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.09%
2/2312 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.04%
1/2312 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.04%
1/2312 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.04%
1/2312 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ECZEMA ASTEATOTIC
|
0.04%
1/2312 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.04%
1/2312 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.04%
1/2312 • Number of events 1
|
|
Social circumstances
MISCARRIAGE OF PARTNER
|
0.04%
1/2312 • Number of events 1
|
|
Social circumstances
PREGNANCY OF PARTNER
|
0.04%
1/2312 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.09%
2/2312 • Number of events 2
|
|
Vascular disorders
HAEMATOMA
|
0.13%
3/2312 • Number of events 3
|
|
Vascular disorders
HAEMORRHAGE
|
0.04%
1/2312 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.04%
1/2312 • Number of events 1
|
|
Vascular disorders
THROMBOSIS
|
0.04%
1/2312 • Number of events 1
|
|
Vascular disorders
VARICOSE VEIN
|
0.04%
1/2312 • Number of events 1
|
|
Vascular disorders
VASCULAR PSEUDOANEURYSM
|
0.04%
1/2312 • Number of events 1
|
Other adverse events
| Measure |
PegIntron Plus Rebetol
n=2312 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.1%
372/2312 • Number of events 721
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
10.3%
239/2312 • Number of events 538
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
19.7%
455/2312 • Number of events 1271
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
7.5%
174/2312 • Number of events 436
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.7%
155/2312 • Number of events 206
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.8%
342/2312 • Number of events 486
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.3%
145/2312 • Number of events 155
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.6%
129/2312 • Number of events 150
|
|
Gastrointestinal disorders
NAUSEA
|
25.4%
587/2312 • Number of events 925
|
|
Gastrointestinal disorders
VOMITING
|
9.1%
210/2312 • Number of events 281
|
|
General disorders
ASTHENIA
|
21.5%
496/2312 • Number of events 1086
|
|
General disorders
CHILLS
|
22.1%
510/2312 • Number of events 768
|
|
General disorders
FATIGUE
|
32.8%
759/2312 • Number of events 1108
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
21.3%
493/2312 • Number of events 1285
|
|
General disorders
INJECTION SITE ERYTHEMA
|
10.3%
237/2312 • Number of events 326
|
|
General disorders
INJECTION SITE REACTION
|
5.2%
120/2312 • Number of events 128
|
|
General disorders
IRRITABILITY
|
17.2%
398/2312 • Number of events 566
|
|
General disorders
PYREXIA
|
38.9%
900/2312 • Number of events 2406
|
|
Investigations
WEIGHT DECREASED
|
6.7%
154/2312 • Number of events 191
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.4%
286/2312 • Number of events 365
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
8.7%
202/2312 • Number of events 222
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.9%
391/2312 • Number of events 686
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.4%
172/2312 • Number of events 216
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
30.9%
714/2312 • Number of events 2249
|
|
Nervous system disorders
DIZZINESS
|
10.9%
251/2312 • Number of events 358
|
|
Nervous system disorders
HEADACHE
|
40.6%
938/2312 • Number of events 2801
|
|
Psychiatric disorders
ANXIETY
|
9.2%
212/2312 • Number of events 289
|
|
Psychiatric disorders
DEPRESSION
|
12.2%
281/2312 • Number of events 383
|
|
Psychiatric disorders
INSOMNIA
|
22.4%
519/2312 • Number of events 772
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.2%
374/2312 • Number of events 447
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.8%
250/2312 • Number of events 313
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
17.0%
392/2312 • Number of events 417
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.5%
196/2312 • Number of events 220
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
15.5%
358/2312 • Number of events 471
|
|
Skin and subcutaneous tissue disorders
RASH
|
9.7%
224/2312 • Number of events 297
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60