Trial Outcomes & Findings for Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED) (NCT NCT00049842)
NCT ID: NCT00049842
Last Updated: 2017-04-04
Results Overview
Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
540 participants
Primary outcome timeframe
Baseline to up to Month-36
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Treatment Phase
STARTED
|
270
|
270
|
|
Treatment Phase
COMPLETED
|
177
|
192
|
|
Treatment Phase
NOT COMPLETED
|
93
|
78
|
|
Follow-up Phase
STARTED
|
218
|
194
|
|
Follow-up Phase
COMPLETED
|
211
|
189
|
|
Follow-up Phase
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Treatment Phase
Adverse Event
|
47
|
12
|
|
Treatment Phase
Withdrawal by Subject
|
35
|
46
|
|
Treatment Phase
Non-compliance with protocol
|
7
|
8
|
|
Treatment Phase
Lost to Follow-up
|
4
|
8
|
|
Treatment Phase
Administrative
|
0
|
3
|
|
Treatment Phase
Did not meet protocol eligibility
|
0
|
1
|
|
Follow-up Phase
Adverse Event
|
6
|
1
|
|
Follow-up Phase
Other
|
1
|
4
|
Baseline Characteristics
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=270 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=270 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
Total
n=540 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=50 years
|
145 participants
n=5 Participants
|
148 participants
n=7 Participants
|
293 participants
n=5 Participants
|
|
Age, Customized
>50 years
|
125 participants
n=5 Participants
|
122 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to Month-36Population: Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group.
Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=270 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=270 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).
Improved
|
44 Participants
|
29 Participants
|
|
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).
No Change
|
162 Participants
|
176 Participants
|
|
Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).
Worsened
|
64 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to Month-36Population: Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group.
Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Changes in liver inflammation defined as follows: Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=270 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=270 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)
Improved
|
54 Participants
|
23 Participants
|
|
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)
No Change
|
195 Participants
|
209 Participants
|
|
Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)
Worsened
|
21 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to Month-36Population: ITT population who had both pre and up to Month-36 METAVIR fibrosis score.
The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline. Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=182 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=166 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)
|
0.13 Units on a scale
Standard Deviation 0.977
|
0.31 Units on a scale
Standard Deviation 1.002
|
SECONDARY outcome
Timeframe: Baseline to up to Month-36Population: Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group.
Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=270 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=270 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline
Improved/No Change
|
206 Participants
|
205 Participants
|
|
The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline
Worsened
|
64 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to Month-36Population: ITT population who had both pre and up to Month-36 METAVIR activity score.
The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline. Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=182 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=166 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Mean Change in the METAVIR Activity Score (Using a Continuous Scale)
|
-0.20 Units on a scale
Standard Deviation 0.709
|
0.11 Units on a scale
Standard Deviation 0.642
|
SECONDARY outcome
Timeframe: Baseline to up to Month-36Population: Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group.
Definitions: Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
Outcome measures
| Measure |
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)
n=270 Participants
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Untreated Control
n=270 Participants
Participants were observed (no treatment given) for 36 months with 4-week follow-up
|
|---|---|---|
|
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.
Improved/No Change
|
249 Participants
|
232 Participants
|
|
Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.
Worsened
|
21 Participants
|
38 Participants
|
Adverse Events
PEG-Intron
Serious events: 53 serious events
Other events: 234 other events
Deaths: 0 deaths
Untreated Control
Serious events: 31 serious events
Other events: 200 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-Intron
n=270 participants at risk
|
Untreated Control
n=270 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CARDIAC AMYLOIDOSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
CORONARY OSTIAL STENOSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.00%
0/270
|
0.74%
2/270 • Number of events 2
|
|
Ear and labyrinth disorders
MENIERE'S DISEASE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Eye disorders
CATARACT
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.37%
1/270 • Number of events 3
|
0.00%
0/270
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.37%
1/270 • Number of events 2
|
0.00%
0/270
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Gastrointestinal disorders
RETROPERITONEAL FIBROSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
General disorders
ASTHENIA
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
General disorders
CHEST PAIN
|
1.1%
3/270 • Number of events 3
|
0.37%
1/270 • Number of events 1
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
General disorders
FATIGUE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
General disorders
HERNIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
General disorders
PYREXIA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/270
|
0.74%
2/270 • Number of events 2
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Immune system disorders
CRYOGLOBULINAEMIA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.74%
2/270 • Number of events 2
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
FUNGAL INFECTION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.37%
1/270 • Number of events 2
|
0.00%
0/270
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Infections and infestations
SEPTIC SHOCK
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
FALL
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
HEPATIC HAEMATOMA
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
NARCOTIC INTOXICATION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
SKIN INJURY
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.74%
2/270 • Number of events 2
|
0.00%
0/270
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PATELLOFEMORAL PAIN SYNDROME
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Musculoskeletal and connective tissue disorders
PLICA SYNDROME
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BURKITT'S LYMPHOMA STAGE IV
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC RENAL CELL CARCINOMA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
COMA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
HEMIPLEGIA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
INTRACRANIAL HAEMATOMA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
LETHARGY
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.37%
1/270 • Number of events 1
|
0.37%
1/270 • Number of events 1
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
DEPRESSION
|
0.37%
1/270 • Number of events 2
|
1.1%
3/270 • Number of events 3
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.37%
1/270 • Number of events 1
|
0.74%
2/270 • Number of events 2
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.00%
0/270
|
0.37%
1/270 • Number of events 3
|
|
Renal and urinary disorders
RENAL COLIC
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/270
|
0.74%
2/270 • Number of events 2
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPNEUMOPATHY
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.74%
2/270 • Number of events 3
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURIGO
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Social circumstances
SUBSTANCE ABUSER
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
ARTERIOVENOUS FISTULA
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
HYPOTENSION
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/270
|
0.37%
1/270 • Number of events 1
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.37%
1/270 • Number of events 1
|
0.00%
0/270
|
Other adverse events
| Measure |
PEG-Intron
n=270 participants at risk
|
Untreated Control
n=270 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
11.9%
32/270 • Number of events 98
|
5.6%
15/270 • Number of events 20
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
6.7%
18/270 • Number of events 39
|
1.9%
5/270 • Number of events 10
|
|
Endocrine disorders
HYPOTHYROIDISM
|
7.4%
20/270 • Number of events 25
|
1.9%
5/270 • Number of events 5
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.6%
15/270 • Number of events 18
|
5.2%
14/270 • Number of events 17
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.1%
22/270 • Number of events 23
|
8.1%
22/270 • Number of events 30
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.4%
28/270 • Number of events 40
|
5.9%
16/270 • Number of events 22
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
18/270 • Number of events 19
|
8.1%
22/270 • Number of events 26
|
|
Gastrointestinal disorders
NAUSEA
|
8.5%
23/270 • Number of events 28
|
5.9%
16/270 • Number of events 16
|
|
General disorders
ASTHENIA
|
17.0%
46/270 • Number of events 92
|
11.1%
30/270 • Number of events 38
|
|
General disorders
CHILLS
|
5.2%
14/270 • Number of events 17
|
1.1%
3/270 • Number of events 3
|
|
General disorders
FATIGUE
|
24.4%
66/270 • Number of events 82
|
21.9%
59/270 • Number of events 68
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
12.6%
34/270 • Number of events 59
|
1.5%
4/270 • Number of events 4
|
|
General disorders
INJECTION SITE ERYTHEMA
|
6.7%
18/270 • Number of events 219
|
0.00%
0/270
|
|
General disorders
INJECTION SITE REACTION
|
6.3%
17/270 • Number of events 17
|
0.37%
1/270 • Number of events 1
|
|
General disorders
IRRITABILITY
|
11.9%
32/270 • Number of events 43
|
4.8%
13/270 • Number of events 13
|
|
General disorders
PYREXIA
|
11.1%
30/270 • Number of events 94
|
4.4%
12/270 • Number of events 13
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
3.3%
9/270 • Number of events 11
|
5.9%
16/270 • Number of events 17
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.0%
19/270 • Number of events 26
|
5.2%
14/270 • Number of events 24
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
7.8%
21/270 • Number of events 26
|
3.7%
10/270 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.5%
50/270 • Number of events 79
|
14.8%
40/270 • Number of events 47
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.9%
32/270 • Number of events 46
|
8.9%
24/270 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.0%
46/270 • Number of events 228
|
7.4%
20/270 • Number of events 22
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
5.9%
16/270 • Number of events 18
|
3.3%
9/270 • Number of events 10
|
|
Nervous system disorders
DIZZINESS
|
5.6%
15/270 • Number of events 21
|
4.1%
11/270 • Number of events 11
|
|
Nervous system disorders
HEADACHE
|
28.1%
76/270 • Number of events 429
|
8.9%
24/270 • Number of events 31
|
|
Psychiatric disorders
ANXIETY
|
9.3%
25/270 • Number of events 34
|
9.3%
25/270 • Number of events 35
|
|
Psychiatric disorders
DEPRESSION
|
12.2%
33/270 • Number of events 41
|
8.9%
24/270 • Number of events 34
|
|
Psychiatric disorders
INSOMNIA
|
20.7%
56/270 • Number of events 88
|
17.0%
46/270 • Number of events 58
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.5%
23/270 • Number of events 25
|
5.9%
16/270 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
14.1%
38/270 • Number of events 43
|
7.8%
21/270 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.6%
26/270 • Number of events 29
|
2.6%
7/270 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.3%
36/270 • Number of events 42
|
5.9%
16/270 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.4%
20/270 • Number of events 23
|
2.6%
7/270 • Number of events 9
|
|
Vascular disorders
HYPERTENSION
|
7.0%
19/270 • Number of events 24
|
10.0%
27/270 • Number of events 32
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No public presentation/publication of any interim results will be made by any principal investigator (PI) or any other member of the study staff without the Sponsor's prior written consent. The PI further agrees to provide to the sponsor 30 days prior to submission, review copies that report any results of the study. The sponsor shall have the right to review, comment, and edit. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues/disagreement.
- Publication restrictions are in place
Restriction type: OTHER