Safety and Efficacy of SCH 503034 in Previously Untreated... | NCT00423670 | Trialant
NCT00423670
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 5, 2017Actual
Enrollment
765Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C
Interventions
boceprevir (SCH 503034)
peginterferon-alfa 2b (PegIntron)
ribavirin
ribavirin (low-dose)
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00423670
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P03523
Secondary IDs
ID
Type
Description
Link
EudraCT No. 2006-002543-92
Brief Title
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Official Title
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2007
Primary Completion Date
Aug 2008Actual
Completion Date
Nov 2008Actual
First Submitted Date
Jan 17, 2007
First Submission Date that Met QC Criteria
Jan 17, 2007
First Posted Date
Jan 18, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 13, 2011
Results First Submitted that Met QC Criteria
May 13, 2011
Results First Posted Date
Jun 15, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 17, 2009
Certification/Extension First Submitted that Passed QC Review
Oct 1, 2009
Certification/Extension First Posted Date
Oct 5, 2009Estimated
Last Update Submitted Date
Mar 8, 2017
Last Update Posted Date
Apr 5, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
Detailed Description
The study was conducted in 2 parts.
Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared:
PegIntron and ribavirin for 48 weeks (Arm 1 - Control)
PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2)
Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and boceprevir for 24 weeks (Arm 3)
PegIntron, ribavirin and boceprevir for 48 weeks (Arm 4)
Lead-in with PegIntron and ribavirin for 4 weeks, followed by PegIntron, ribavirin and boceprevir for 44 weeks (Arm 5)
Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks. All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm (Arm 8).
Part 2 of the study assessed the safety and efficacy of low dose ribavirin (400-1000 mg/day) and compared:
PegIntron, ribavirin (800-1400 mg/day) and boceprevir for 48 weeks (Arm 6)
PegIntron, low-dose ribavirin (400-1000 mg/day) and boceprevir for 48 weeks (Arm 7)
Follow-up for all participants was up to 72 weeks after randomization.
Conditions Module
Conditions
Chronic Hepatitis C
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
765Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1. PEG +RBV for 48 Wks (Part I)
Active Comparator
Participants treated with PegIntron (1.5 μg/kg, once weekly [QW]) and Ribavirin (800 to 1400 mg/day) for 48 weeks.
Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and boceprevir (800 mg three times daily [TID]) for 24 additional weeks. The participants that crossed over to receive boceprevir formed Arm 8. The total treatment duration was up to 54 weeks.
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Experimental
Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)
Experimental
Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Experimental
Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
boceprevir (SCH 503034)
Drug
200 mg capsules taken as 800 mg orally three times daily (TID)
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Sustained Virologic Response (SVR)
Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).
A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.
From follow-up week (FW) 24 up to end of follow-up (EOF)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 60 years;
Body weight between 45 and 125 kg;
Documented chronic hepatitis C genotype 1;
Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
Written informed consent.
Exclusion Criteria:
Include, but are not limited to, the following:
Prior treatment for hepatitis C;
Co-infection with HIV or hepatitis B virus (HBsAg positive);
Evidence of decompensated liver disease;
Diabetic and hypertensive participants with clinically significant ocular exam findings;
Pre-existing psychiatric condition, including but not limited to:
Current moderate or severe depression;
History of depression associated with any of the following:
Hospitalization for depression;
Electroconvulsive therapy for depression;
Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
Suicidal or homicidal ideation and/or attempt;
History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
Past history or current use of lithium;
Past history or current use of antipsychotic drugs for listed conditions.
Substance abuse within protocol specified timeframes;
Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
Active or suspected malignancy or history of malignancy within the past 5 years;
Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
Hemoglobin <12 g/dL for females and <13 g/dL for males;
Neutrophils <1500 mm^3; Blacks: <1200/mm^3;
Platelets <100,000/mm^3;
Other clinically significant laboratory test abnormalities.
Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK; SPRINT-1 investigators. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. doi: 10.1016/S0140-6736(10)60934-8. Epub 2010 Aug 6.
Participants in Arm 1 (Part I) who had detectable Hepatitis C Virus-ribonucleic acid (HCV-RNA) at Treatment Week (TW) 24 were offered boceprevir in addition to PegIntron and ribavirin for an additional 24 weeks of treatment, and switched to a new arm, Arm 8.
Recruitment Details
765 participants were screened in the study, 598 were randomized of which 3 participants were not
treated (Arm 1-7). Participants were assigned to Part I (with standard dosing for ribavirin) or Part II (to explore low-dose ribavirin). All participants that completed or discontinued treatment were scheduled to enter follow-up phase per protocol.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
Canada
France
Germany
Italy
Netherlands
Spain
Switzerland
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)
Experimental
Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
Experimental
Participants receiving PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
Experimental
Participants receiving PegIntron (1.5 μg/kg QW), low-dose ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks (Arm 7) during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin (low-dose)
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)
Experimental
Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with
PegIntron (1.5 μg/kg QW), and ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
Drug: boceprevir (SCH 503034)
Drug: peginterferon-alfa 2b (PegIntron)
Drug: ribavirin
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)
Boceprevir, Victrelis, SCH 503034
peginterferon-alfa 2b (PegIntron)
Drug
1.5 μg/kg subcutaneously (SC) once weekly (QW)
Arm 1. PEG +RBV for 48 Wks (Part I)
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)
ribavirin
Drug
200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
Arm 1. PEG +RBV for 48 Wks (Part I)
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)
ribavirin (low-dose)
Drug
200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
From FW 24 up to EOF
Number of Participants With SVR Based on Duration of Boceprevir Treatment
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
From FW 24 up to EOF
Number of Participants Negative for HCV-RNA at FW 12
Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
At FW 12
Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
72 weeks post randomization
Number of Participants With an Early Virologic Response (EVR) That Achieved SVR
Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
At TW 12, and at FW 24 up to EOF
Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
At FW 12 and FW 24 up to EOF
Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL.
At FW 24 up to EOF and at 72 weeks post randomization
FG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
FG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
FG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
FG004
Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
FG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
FG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
FG007
Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
FG000104 subjects
FG001107 subjects
FG002103 subjects
FG003103 subjects
FG004103 subjects
FG00516 subjects
FG00659 subjects
FG00736 subjectsArm 8 were Arm 1 participants that were positive for HCV-RNA at TW 24 and had the option to switch.
COMPLETED
FG00052 subjects
FG00177 subjects
FG00276 subjects
FG00363 subjects
FG00476 subjects
FG0058 subjects
FG00628 subjects
FG00715 subjects
NOT COMPLETED
FG00052 subjects
FG00130 subjects
FG00227 subjects
FG00340 subjects
FG00427 subjects
FG0058 subjects
FG00631 subjects
FG00721 subjects
Type
Comment
Reasons
Switched to Arm 8 at TW 24
FG00036 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0008 subjects
FG00112 subjects
FG00215 subjects
FG00320 subjects
FG004
Protocol-defined clinical event
FG0000 subjects
FG0017 subjects
FG0024 subjects
FG00312 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG004
Subject withdrew (not treatment related)
FG0003 subjects
FG0019 subjects
FG0024 subjects
FG0034 subjects
FG004
Investigator decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-compliance with protocol
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00097 subjects
FG001100 subjects
FG00296 subjects
FG00396 subjects
FG00491 subjects
FG00514 subjects
FG00650 subjects
FG00735 subjects
COMPLETED
FG00094 subjects
FG00184 subjects
FG00285 subjects
FG00391 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG00116 subjects
FG00211 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG00112 subjects
FG0028 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
BG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
BG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
BG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
BG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
BG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
BG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000104
BG001107
BG002103
BG003103
BG004103
BG00516
BG00659
BG007595
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Overall age characteristics were displayed for Arm 1 through Arm 7. Participants from Arm 1 (Part I) who had detectable HCV-RNA at TW 24, had the option to switch to a new arm, Arm 8.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.3± 6.9
BG00146.4± 8.0
BG00247.7± 7.4
BG003
Sex: Female, Male
Overall gender characteristics were displayed for Arm 1 through Arm 7. Participants from Arm 1 (Part I) who had detectable HCV-RNA TW 24, had the option to switch to a new arm, Arm 8.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00034
BG00144
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Sustained Virologic Response (SVR)
Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).
A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.
Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Posted
Number
Participants
From follow-up week (FW) 24 up to end of follow-up (EOF)
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Units
Counts
Participants
OG000104
OG001107
OG002103
OG003
Title
Denominators
Categories
Title
Measurements
OG00039
OG00158
OG00258
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel Haenszel Chi-square test
Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.
0.0126
Percent difference in SVR
16.7
2-Sided
95
3.5
30
Superiority or Other
OG000
OG002
Cochran-Mantel Haenszel Chi-square test
Secondary
Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Posted
Number
Participants
From FW 24 up to EOF
ID
Title
Description
OG000
Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG001
Arm 2 and Arm 4. PEG + RBV + BOC
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Secondary
Number of Participants With SVR Based on Duration of Boceprevir Treatment
Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Posted
Number
Participants
From FW 24 up to EOF
ID
Title
Description
OG000
Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
OG001
Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
Secondary
Number of Participants Negative for HCV-RNA at FW 12
Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).
Posted
Number
Participants
At FW 12
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Secondary
Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Posted
Number
Participants
72 weeks post randomization
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Secondary
Number of Participants With an Early Virologic Response (EVR) That Achieved SVR
Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Participants with an early virologic response (EVR).
Posted
Number
Participants
At TW 12, and at FW 24 up to EOF
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
Secondary
Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.
Participants with undetectable HCV-RNA at FW 12.
Posted
Number
Participants
At FW 12 and FW 24 up to EOF
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
Secondary
Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.
Participants missing data at FW 24 were considered to achieve SVR if
he/she had undetectable HCV-RNA at FW 12 or later
if he/she returned later to the study center and had undetectable HCV-RNA.
HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL.
Participants who achieved SVR.
Posted
Number
Participants
At FW 24 up to EOF and at 72 weeks post randomization
ID
Title
Description
OG000
Arm 1. PEG +RBV for 48 Wks (Part I)
PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
OG001
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
OG002
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PEG +RBV for 48 Wks (Part I)
Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.
• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Adverse events for 36 participants after they crossed over to Arm 8 are not included.
8
104
102
104
EG001
PEG + RBV + BOC for 28 Wks (Part I)
Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
10
107
106
107
EG002
PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)
Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
8
103
102
103
EG003
PEG +RBV + BOC for 48 Wks (Part I)
Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
10
103
103
103
EG004
PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)
Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
6
103
102
103
EG005
PEG + RBV + BOC for 48 Wks (Part II)
Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1
16
16
16
EG006
PEG +Low-dose RBV + BOC for 48 Wks (Part II)
Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
3
59
59
59
EG007
PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
2
36
29
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG0030 events0 affected103 at risk
EG0040 events0 affected103 at risk
EG0050 events0 affected16 at risk
EG0061 events1 affected59 at risk
EG0070 events0 affected36 at risk
NEUTROPENIA
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events2 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PERICARDITIS
Cardiac disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DEAFNESS UNILATERAL
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DIPLOPIA
Eye disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RETINAL ISCHAEMIA
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RETINOPATHY
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SCOTOMA
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
NAUSEA
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PERIODONTAL DISEASE
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PERITONEAL HAEMORRHAGE
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
VOMITING
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
ASTHENIA
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CHEST PAIN
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
FATIGUE
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
LOCAL SWELLING
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
MULTI-ORGAN FAILURE
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PYREXIA
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CELLULITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CORNEAL INFECTION
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ERYSIPELAS
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
GASTROENTERITIS
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
LOBAR PNEUMONIA
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PNEUMONIA
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PNEUMONIA STREPTOCOCCAL
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
STAPHYLOCOCCAL SEPSIS
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
VULVAL ABSCESS
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ACCIDENTAL OVERDOSE
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DRUG TOXICITY
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
FALL
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HAND FRACTURE
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
BLOOD AMYLASE INCREASED
Investigations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
LIPASE INCREASED
Investigations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
HYPOVOLAEMIA
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CERVIX CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PARATHYROID TUMOUR BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RENAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
CERVICAL CORD COMPRESSION
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HEADACHE
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
IIIRD NERVE PARALYSIS
Nervous system disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PARAESTHESIA
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
AGGRESSION
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ALCOHOLISM
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ANXIETY
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DEPENDENCE
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DEPRESSION
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HOMICIDAL IDEATION
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PANIC ATTACK
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PARANOIA
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
UMBILICAL HERNIA REPAIR
Surgical and medical procedures
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
Systematic Assessment
EG00055 events35 affected104 at risk
EG00196 events59 affected107 at risk
EG00280 events55 affected103 at risk
EG00379 events54 affected103 at risk
EG00488 events58 affected103 at risk
EG00522 events10 affected16 at risk
EG00639 events14 affected59 at risk
EG00713 events13 affected36 at risk
LEUKOPENIA
Blood and lymphatic system disorders
Systematic Assessment
EG00015 events6 affected104 at risk
EG00137 events7 affected107 at risk
EG00212 events5 affected103 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
Systematic Assessment
EG00032 events12 affected104 at risk
EG00182 events23 affected107 at risk
EG00230 events16 affected103 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0017 events5 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PALPITATIONS
Cardiac disorders
Systematic Assessment
EG0003 events2 affected104 at risk
EG0011 events1 affected107 at risk
EG0022 events2 affected103 at risk
EG003
TINNITUS
Ear and labyrinth disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0023 events3 affected103 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
Systematic Assessment
EG0006 events6 affected104 at risk
EG0012 events2 affected107 at risk
EG0023 events3 affected103 at risk
EG003
CONJUNCTIVAL DISCOLOURATION
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
CONJUNCTIVITIS
Eye disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
DRY EYE
Eye disorders
Systematic Assessment
EG0004 events4 affected104 at risk
EG0011 events1 affected107 at risk
EG0024 events3 affected103 at risk
EG003
EYE IRRITATION
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
RETINAL HAEMORRHAGE
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RETINOPATHY
Eye disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
VISION BLURRED
Eye disorders
Systematic Assessment
EG0007 events7 affected104 at risk
EG0016 events6 affected107 at risk
EG0022 events2 affected103 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0011 events1 affected107 at risk
EG0025 events5 affected103 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
Systematic Assessment
EG00012 events9 affected104 at risk
EG0014 events4 affected107 at risk
EG0026 events6 affected103 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
Systematic Assessment
EG0005 events5 affected104 at risk
EG0018 events7 affected107 at risk
EG0027 events5 affected103 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0013 events2 affected107 at risk
EG0024 events3 affected103 at risk
EG003
CHEILITIS
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
Systematic Assessment
EG00013 events11 affected104 at risk
EG0015 events5 affected107 at risk
EG00217 events14 affected103 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
Systematic Assessment
EG00031 events23 affected104 at risk
EG00140 events28 affected107 at risk
EG00229 events27 affected103 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
Systematic Assessment
EG0005 events5 affected104 at risk
EG00115 events14 affected107 at risk
EG0028 events8 affected103 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
Systematic Assessment
EG0009 events8 affected104 at risk
EG0018 events6 affected107 at risk
EG0028 events8 affected103 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
Systematic Assessment
EG0005 events5 affected104 at risk
EG00112 events11 affected107 at risk
EG0024 events3 affected103 at risk
EG003
GINGIVAL PAIN
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected103 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
Systematic Assessment
EG0007 events7 affected104 at risk
EG0016 events5 affected107 at risk
EG0022 events2 affected103 at risk
EG003
NAUSEA
Gastrointestinal disorders
Systematic Assessment
EG00052 events45 affected104 at risk
EG00150 events41 affected107 at risk
EG00253 events42 affected103 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0012 events2 affected107 at risk
EG0022 events2 affected103 at risk
EG003
SALIVARY HYPERSECRETION
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
STOMACH DISCOMFORT
Gastrointestinal disorders
Systematic Assessment
EG0004 events3 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
STOMATITIS
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0018 events7 affected107 at risk
EG0025 events5 affected103 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0013 events3 affected107 at risk
EG0021 events1 affected103 at risk
EG003
VOMITING
Gastrointestinal disorders
Systematic Assessment
EG0007 events5 affected104 at risk
EG00127 events24 affected107 at risk
EG00221 events15 affected103 at risk
EG003
ASTHENIA
General disorders
Systematic Assessment
EG00018 events14 affected104 at risk
EG00112 events9 affected107 at risk
EG00218 events9 affected103 at risk
EG003
CHEST DISCOMFORT
General disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
CHILLS
General disorders
Systematic Assessment
EG00038 events35 affected104 at risk
EG00139 events31 affected107 at risk
EG00234 events31 affected103 at risk
EG003
FATIGUE
General disorders
Systematic Assessment
EG00062 events57 affected104 at risk
EG00178 events65 affected107 at risk
EG00280 events70 affected103 at risk
EG003
IMPAIRED HEALING
General disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
Systematic Assessment
EG00037 events25 affected104 at risk
EG00126 events24 affected107 at risk
EG00222 events21 affected103 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
Systematic Assessment
EG00013 events13 affected104 at risk
EG0019 events9 affected107 at risk
EG00214 events14 affected103 at risk
EG003
INJECTION SITE RASH
General disorders
Systematic Assessment
EG0006 events6 affected104 at risk
EG0013 events3 affected107 at risk
EG0020 events0 affected103 at risk
EG003
INJECTION SITE REACTION
General disorders
Systematic Assessment
EG00012 events10 affected104 at risk
EG0019 events9 affected107 at risk
EG0025 events5 affected103 at risk
EG003
IRRITABILITY
General disorders
Systematic Assessment
EG00023 events23 affected104 at risk
EG00126 events25 affected107 at risk
EG00227 events24 affected103 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PAIN
General disorders
Systematic Assessment
EG0008 events8 affected104 at risk
EG00111 events11 affected107 at risk
EG00210 events9 affected103 at risk
EG003
PYREXIA
General disorders
Systematic Assessment
EG00055 events35 affected104 at risk
EG00135 events27 affected107 at risk
EG00234 events27 affected103 at risk
EG003
TEMPERATURE INTOLERANCE
General disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
BRONCHITIS
Infections and infestations
Systematic Assessment
EG0003 events3 affected104 at risk
EG0016 events4 affected107 at risk
EG0021 events1 affected103 at risk
EG003
EAR INFECTION
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
EYE INFECTION
Infections and infestations
Systematic Assessment
EG0002 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
INFLUENZA
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0014 events3 affected107 at risk
EG0020 events0 affected103 at risk
EG003
LARYNGITIS
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PHARYNGITIS
Infections and infestations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0022 events2 affected103 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
RECTAL ABSCESS
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SINUSITIS
Infections and infestations
Systematic Assessment
EG0003 events3 affected104 at risk
EG0014 events3 affected107 at risk
EG0023 events3 affected103 at risk
EG003
TINEA VERSICOLOUR
Infections and infestations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Systematic Assessment
EG0003 events3 affected104 at risk
EG0017 events7 affected107 at risk
EG0021 events1 affected103 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
Systematic Assessment
EG0004 events3 affected104 at risk
EG0013 events3 affected107 at risk
EG0023 events3 affected103 at risk
EG003
BLOOD URIC ACID INCREASED
Investigations
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HEART RATE INCREASED
Investigations
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
WEIGHT DECREASED
Investigations
Systematic Assessment
EG0009 events9 affected104 at risk
EG0016 events6 affected107 at risk
EG0028 events8 affected103 at risk
EG003
ANOREXIA
Metabolism and nutrition disorders
Systematic Assessment
EG00011 events10 affected104 at risk
EG00110 events10 affected107 at risk
EG0028 events8 affected103 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
Systematic Assessment
EG00013 events12 affected104 at risk
EG0017 events7 affected107 at risk
EG00215 events14 affected103 at risk
EG003
HYPERAMYLASAEMIA
Metabolism and nutrition disorders
Systematic Assessment
EG0002 events1 affected104 at risk
EG0014 events3 affected107 at risk
EG0021 events1 affected103 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0023 events3 affected103 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00024 events21 affected104 at risk
EG00120 events14 affected107 at risk
EG00226 events22 affected103 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0005 events5 affected104 at risk
EG0015 events5 affected107 at risk
EG0027 events7 affected103 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0007 events5 affected104 at risk
EG0014 events4 affected107 at risk
EG0024 events4 affected103 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0004 events4 affected104 at risk
EG0015 events4 affected107 at risk
EG0020 events0 affected103 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0006 events5 affected104 at risk
EG0015 events4 affected107 at risk
EG0020 events0 affected103 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00017 events17 affected104 at risk
EG00134 events31 affected107 at risk
EG00220 events20 affected103 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0005 events4 affected104 at risk
EG0014 events4 affected107 at risk
EG0020 events0 affected103 at risk
EG003
AMNESIA
Nervous system disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0011 events1 affected107 at risk
EG0023 events2 affected103 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
Systematic Assessment
EG0005 events4 affected104 at risk
EG0017 events7 affected107 at risk
EG0029 events9 affected103 at risk
EG003
DIZZINESS
Nervous system disorders
Systematic Assessment
EG00018 events16 affected104 at risk
EG00123 events19 affected107 at risk
EG00218 events16 affected103 at risk
EG003
DYSGEUSIA
Nervous system disorders
Systematic Assessment
EG00010 events9 affected104 at risk
EG00125 events23 affected107 at risk
EG00228 events27 affected103 at risk
EG003
HEADACHE
Nervous system disorders
Systematic Assessment
EG00060 events45 affected104 at risk
EG00166 events51 affected107 at risk
EG00246 events41 affected103 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0012 events2 affected107 at risk
EG0022 events2 affected103 at risk
EG003
MIGRAINE
Nervous system disorders
Systematic Assessment
EG0003 events2 affected104 at risk
EG0011 events1 affected107 at risk
EG0022 events2 affected103 at risk
EG003
PARAESTHESIA
Nervous system disorders
Systematic Assessment
EG0004 events3 affected104 at risk
EG0016 events5 affected107 at risk
EG0024 events4 affected103 at risk
EG003
SCIATICA
Nervous system disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SOMNOLENCE
Nervous system disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
TREMOR
Nervous system disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0013 events3 affected107 at risk
EG0021 events1 affected103 at risk
EG003
TRIGEMINAL NEURALGIA
Nervous system disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ANXIETY
Psychiatric disorders
Systematic Assessment
EG00021 events18 affected104 at risk
EG00119 events16 affected107 at risk
EG00210 events9 affected103 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0022 events2 affected103 at risk
EG003
DEPRESSION
Psychiatric disorders
Systematic Assessment
EG00025 events22 affected104 at risk
EG00129 events22 affected107 at risk
EG00223 events20 affected103 at risk
EG003
INSOMNIA
Psychiatric disorders
Systematic Assessment
EG00050 events40 affected104 at risk
EG00140 events36 affected107 at risk
EG00237 events29 affected103 at risk
EG003
MOOD SWINGS
Psychiatric disorders
Systematic Assessment
EG0003 events2 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
CHROMATURIA
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HAEMATURIA
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected103 at risk
EG003
NOCTURIA
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0014 events4 affected107 at risk
EG0026 events6 affected103 at risk
EG003
URETHRAL OBSTRUCTION
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected103 at risk
EG003
ERECTILE DYSFUNCTION
Reproductive system and breast disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
VULVOVAGINAL PRURITUS
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00026 events20 affected104 at risk
EG00127 events18 affected107 at risk
EG00225 events22 affected103 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00020 events15 affected104 at risk
EG00123 events18 affected107 at risk
EG00212 events12 affected103 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0006 events6 affected104 at risk
EG0016 events6 affected107 at risk
EG0022 events2 affected103 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0014 events3 affected107 at risk
EG0022 events2 affected103 at risk
EG003
INCREASED UPPER AIRWAY SECRETION
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected107 at risk
EG0023 events3 affected103 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0012 events2 affected107 at risk
EG00212 events11 affected103 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected103 at risk
EG003
POSTNASAL DRIP
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0005 events5 affected104 at risk
EG0012 events2 affected107 at risk
EG0020 events0 affected103 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 events2 affected104 at risk
EG0011 events1 affected107 at risk
EG0023 events3 affected103 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00028 events27 affected104 at risk
EG00141 events36 affected107 at risk
EG00234 events30 affected103 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 events4 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00017 events17 affected104 at risk
EG00114 events12 affected107 at risk
EG00210 events9 affected103 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0007 events4 affected104 at risk
EG0012 events2 affected107 at risk
EG0028 events7 affected103 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 events3 affected104 at risk
EG0014 events4 affected107 at risk
EG0026 events6 affected103 at risk
EG003
INCREASED TENDENCY TO BRUISE
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected107 at risk
EG0021 events1 affected103 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00020 events16 affected104 at risk
EG00123 events19 affected107 at risk
EG00228 events19 affected103 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0007 events6 affected104 at risk
EG0015 events3 affected107 at risk
EG0026 events6 affected103 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 events2 affected104 at risk
EG0019 events7 affected107 at risk
EG0026 events5 affected103 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0012 events2 affected107 at risk
EG0023 events3 affected103 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0007 events5 affected104 at risk
EG0017 events6 affected107 at risk
EG0021 events1 affected103 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00010 events8 affected104 at risk
EG0019 events9 affected107 at risk
EG0029 events8 affected103 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 events4 affected104 at risk
EG0011 events1 affected107 at risk
EG0024 events4 affected103 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0004 events4 affected104 at risk
EG0014 events4 affected107 at risk
EG0021 events1 affected103 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected104 at risk
EG0013 events3 affected107 at risk
EG0020 events0 affected103 at risk
EG003
HYPERTENSION
Vascular disorders
Systematic Assessment
EG0006 events6 affected104 at risk
EG0012 events2 affected107 at risk
EG0024 events4 affected103 at risk
EG003
HYPOTENSION
Vascular disorders
Systematic Assessment
EG0000 events0 affected104 at risk
EG0014 events3 affected107 at risk
EG0021 events1 affected103 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Principal Investigator agrees to provide to the sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations and texts of any transmission through any electronic media) that report any results of the study.
Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.
0.0048
Percent difference in SVR
18.8
2-Sided
95
5.5
32.2
Superiority or Other
OG000
OG003
Cochran-Mantel Haenszel Chi-square test
Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.
<0.0001
Percent difference in SVR
29.5
2-Sided
95
16.5
42.5
Superiority or Other
OG000
OG004
Cochran-Mantel Haenszel Chi-square test
Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.
<0.0001
Percent difference in SVR
37.3
2-Sided
95
24.7
49.8
Superiority or Other
Units
Counts
Participants
OG000206
OG001210
Title
Denominators
Categories
Title
Measurements
OG000135
OG001127
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel Chi-Square Test
Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.
0.2864
Percent difference in SVR rates
5.1
2-Sided
95
-4.2
14.3
Superiority or Other
Units
Counts
Participants
OG000206
OG001210
Title
Denominators
Categories
Title
Measurements
OG000146
OG001116
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel Chi-Square Test
Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.
0.0009
Percent difference in SVR rates
15.6
2-Sided
95
6.5
24.8
Superiority or Other
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Units
Counts
Participants
OG000104
OG001107
OG002103
OG003103
OG004103
OG00516
OG00659
Title
Denominators
Categories
HCV-RNA negative
Title
Measurements
OG00039
OG00160
OG00259
OG00369
OG00476
OG0058
OG00621
Missing HCV-RNA at FW 12
Title
Measurements
OG00042
OG00113
OG00211
OG003
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Units
Counts
Participants
OG000104
OG001107
OG002103
OG003103
OG004103
OG00516
OG00659
Title
Denominators
Categories
HCV-RNA negative
Title
Measurements
OG00038
OG00153
OG00256
OG00367
OG00476
OG0058
OG00620
Missing HCV-RNA at 72 weeks post randomization
Title
Measurements
OG00045
OG00125
OG00218
OG003
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Units
Counts
Participants
OG00037
OG00185
OG00285
OG00381
OG00485
OG00511
OG00635
Title
Denominators
Categories
Title
Measurements
OG00032
OG00158
OG00258
OG00368
OG00477
OG0058
OG00621
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Units
Counts
Participants
OG00039
OG00160
OG00259
OG00369
OG00476
OG0058
OG00621
Title
Denominators
Categories
HCV-RNA negative at EOF
Title
Measurements
OG00039
OG00158
OG00258
OG00369
OG00476
OG0058
OG00620
HCV-RNA positive at EOF
Title
Measurements
OG0000
OG0012
OG0021
OG003
Missing HCV-RNA at EOF
Title
Measurements
OG0000
OG0010
OG0020
OG003
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
OG003
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
OG004
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)
PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
OG005
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
OG006
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.