Trial Outcomes & Findings for Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1) (NCT NCT00724451)
NCT ID: NCT00724451
Last Updated: 2015-09-25
Results Overview
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
Recruitment status
COMPLETED
Target enrollment
1128 participants
Primary outcome timeframe
Measured at baseline
Results posted on
2015-09-25
Participant Flow
Participant milestones
| Measure |
Participants With Chronic Hepatitis C (CHC)
Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
|
|---|---|
|
Overall Study
STARTED
|
1128
|
|
Overall Study
Received Antiviral Treatment
|
500
|
|
Overall Study
COMPLETED
|
326
|
|
Overall Study
NOT COMPLETED
|
802
|
Reasons for withdrawal
| Measure |
Participants With Chronic Hepatitis C (CHC)
Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
|
|---|---|
|
Overall Study
Excluded - Prior Use of Peginterferon
|
7
|
|
Overall Study
Excluded - Hepatitis C Virus Negative
|
3
|
|
Overall Study
Not Eligible for Treatment
|
431
|
|
Overall Study
Participant Refused Treatment
|
89
|
|
Overall Study
Never Started Treatment
|
89
|
|
Overall Study
Unknown; No Data Sources Available
|
9
|
|
Overall Study
Physician Decision
|
116
|
|
Overall Study
Withdrawal by Subject
|
45
|
|
Overall Study
Investigator + Participant Decision
|
13
|
Baseline Characteristics
Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
Baseline characteristics by cohort
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=1118 Participants
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Age, Customized
18-29 years
|
51 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
119 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
244 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
211 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
263 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
210 participants
n=5 Participants
|
|
Age, Customized
≥80 years
|
20 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
541 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
577 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baselinePopulation: 431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
Outcome measures
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=431 Participants
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Age
|
144 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Mild disease
|
77 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Substance abuse history
|
17 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Treatment postponed
|
7 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Genotype
|
2 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Comorbidity
|
139 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Liver problems
|
41 participants
|
|
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Problems with previous treatment
|
4 participants
|
SECONDARY outcome
Timeframe: 24 weeks after the end of treatment (total of 48 to 72 weeks)Population: Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.
Investigators recorded reasons for treatment discontinuation.
Outcome measures
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=174 Participants
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Disease worsening
|
3 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Side effects
|
27 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Non response
|
44 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Adverse effect
|
32 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Administrative reason
|
5 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Virological response
|
22 participants
|
|
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Other reasons
|
5 participants
|
SECONDARY outcome
Timeframe: 24 to 48 weeksPopulation: 132 of the 500 treated participants failed treatment per Investigator assessment.
Investigators recorded reasons for treatment failure whether or not treatment was completed.
Outcome measures
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=132 Participants
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Number of Participants With Treatment Failure by Reason for Failure
Disease relapse
|
71 participants
|
|
Number of Participants With Treatment Failure by Reason for Failure
Non-responder
|
61 participants
|
Adverse Events
Participants With Chronic Hepatitis C (CHC)
Serious events: 6 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=500 participants at risk
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Asthenia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Hemiplegia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Polyneuropathy
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Vascular disorders
Haemorrhage
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
Other adverse events
| Measure |
Participants With Chronic Hepatitis C (CHC)
n=500 participants at risk
Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
|
|---|---|
|
Infections and infestations
Herpes simplex
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.8%
64/500 • Number of events 65
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
10/500 • Number of events 10
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.6%
23/500 • Number of events 23
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
5/500 • Number of events 5
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Cardiac disorders
Tachycardia
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Ear and labyrinth disorders
Deafness
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Endocrine disorders
Hyperthyroidism
|
0.80%
4/500 • Number of events 4
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
7/500 • Number of events 7
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Eye disorders
Chalazion
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Eye disorders
Eye pain
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Eye disorders
Visual acuity reduced
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
6/500 • Number of events 7
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Aerophagia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Ascites
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Constipation
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
4/500 • Number of events 4
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Dry mouth
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Infections and infestations
Pneumonia
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Gastritis
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Infections and infestations
Tooth abscess
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Gingivitis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Ileus
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
8/500 • Number of events 8
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Asthenia
|
9.4%
47/500 • Number of events 47
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Chest pain
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Chills
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Fatigue
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Hyperpyrexia
|
1.4%
7/500 • Number of events 7
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Influenza like illness
|
3.8%
19/500 • Number of events 19
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Injection site reaction
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Irritability
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Malaise
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Pain
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
General disorders
Pyrexia
|
3.8%
19/500 • Number of events 19
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Infections and infestations
Cystitis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Investigations
Platelet count decreased
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Investigations
Serum ferritin increased
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Investigations
Thyroid function test abnormal
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Investigations
Weight decreased
|
2.4%
12/500 • Number of events 12
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
6/500 • Number of events 6
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.80%
4/500 • Number of events 4
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Dementia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Disturbance in attention
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Dizziness
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Dysgeusia
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Headache
|
2.4%
12/500 • Number of events 12
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Paraesthesia
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Polyneuropathy
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Nervous system disorders
Syncope
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Agitation
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Anxiety
|
2.2%
11/500 • Number of events 11
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Apathy
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Depression
|
1.6%
8/500 • Number of events 8
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Insomnia
|
2.2%
11/500 • Number of events 11
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Mood altered
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Nervousness
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Psychiatric disorders
Panic attack
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Renal and urinary disorders
Dysuria
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
8/500 • Number of events 8
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspoenia
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
6/500 • Number of events 6
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.8%
14/500 • Number of events 14
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.60%
3/500 • Number of events 3
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
7/500 • Number of events 7
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Vascular disorders
Hypertension
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Vascular disorders
Hypotension
|
0.20%
1/500 • Number of events 1
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
2/500 • Number of events 2
500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
|
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 principal investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The principal investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication.
- Publication restrictions are in place
Restriction type: OTHER