Boceprevir (SCH 503034) Plus Peg-Intron, With and Without... | NCT00160251

Label	Type	Description	Intervention Names
Arm 1A: PegIntron (PEG) + Ribavirin (RBV)	Active Comparator	A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.	Biological: PegIntron (PEG) Drug: Ribavirin (RBV)
Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400	Active Comparator	A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.	Drug: Boceprevir (BOC) Biological: PegIntron (PEG) Drug: Ribavirin (RBV)
Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.	Drug: Boceprevir (BOC) Biological: PegIntron (PEG)
Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Name	Type	Description	Arm Group Labels	Other Names
Boceprevir (BOC)	Drug	100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID	Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400 Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)

Measure	Description	Time Frame
Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)	Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.	Baseline up to Week 49
Percent of Participants Who Achieved Sustained Virologic Response (SVR)	SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.	Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

Measure	Description	Time Frame
Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA	Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.	Baseline up to Week 73 [24 weeks after EoT]

ID	Title	Description
FG000	Arm 1A: PEG + RBV	A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
FG001	Arm 1B: PEG + RBV + BOC

ID	Title	Description
BG000	Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400	Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks. Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG001	Arm 2: PEG + BOC 100 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG002	Arm 3: PEG + BOC 200 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG003	Arm 5: PEG + RBV + BOC 400	A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG004	Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG005	Arm 7: PEG + BOC 800	A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG00049 BG00148 BG00249 BG00349 BG00497 BG00565 BG006357

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

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.

All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.

For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.

Arm 1A was not analyzed.

For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.

Posted

Number

Percent of participants

Baseline up to Week 49

ID	Title	Description
OG000	Arm 1B: PEG + RBV + BOC 400	A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	Arm 2: PEG + BOC 100 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	Arm 3: PEG + BOC 200 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG003	Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG004	Arm 5: PEG + RBV + BOC 400	A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG005	Arm 7: PEG + BOC 800	A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Units	Counts
Participants	OG00040 OG00148 OG00249 OG003

Title

Denominators

Categories

Title	Measurements
	OG00035.0 OG0016.3 OG00216.3 OG003

Secondary

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.

Number of participants across all treatment arms who achieved negative HCV-RNA

Posted

Number

Percent of participants

Baseline up to Week 73 [24 weeks after EoT]

ID	Title	Description
OG000	0 to ≤ 4 Weeks to First Negative HCV-RNA Group	Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
OG001	>4 to 8 Weeks to First Negative HCV-RNA Group	Participants who achieved first negative HCV RNA between weeks 4 to 8.
OG002	>8 to 12 Weeks to First Negative HCV-RNA Group	Participants who achieved first negative HCV RNA between weeks 8 to 12.
OG003	>12 to 36 Weeks to First Negative HCV-RNA Group	Participants who achieved first negative HCV RNA between weeks 12 to 36.

Secondary

Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:

Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).

Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.

N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).

Posted

Number

Percent of participants

Week 1 and Week 49

ID	Title	Description
OG000	Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400	A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	Arm 5: PEG + RBV + BOC 400	A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Secondary

Percent of Participants With Virologic Response Prior to Amendment 2

Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.

Posted

Number

Percent of participants

Week 3, Week 5, Week 13

ID	Title	Description
OG000	Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400	Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks. Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	Arm 2: PEG + BOC 100 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	Arm 3: PEG + BOC 200 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Secondary

Peak Plasma Concentration of Boceprevir (BOC)

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.

Posted

Mean

Standard Error

ng/mL

All visits during treatment (baseline to Week 49) except Day 1 of Week 1

ID	Title	Description
OG000	BOC 100 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	BOC 200 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	BOC 400 mg Dose	A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Secondary

Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

The dosing interval of 8 hours is represented as the hr in the unit of measure.

Posted

Mean

Standard Error

ng*hr/mL

All visits during treatment (baseline to Week 49) except Day 1 of Week 1

ID	Title	Description
OG000	BOC 100 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	BOC 200 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	BOC 400 mg Dose	A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Secondary

Trough Plasma Concentration Level

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

Posted

Mean

Standard Error

ng/mL

All visits during treatment (baseline to Week 49) except Day 1 of Week 1

ID	Title	Description
OG000	BOC 100 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	BOC 200 mg Dose	A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	BOC 400 mg Dose	A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.

Secondary

Change in Alanine Aminotransferase (ALT) Levels

Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.

Only participants with at least one value for the laboratory test were included.

Posted

Number

Participants

Baseline up to dosing change (> 25 weeks)

ID	Title	Description
OG000	Arm 1A: PEG + RBV	Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
OG001	Arm 1B: PEG + RBV + BOC 400	Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002	Arm 2: PEG + BOC 100 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG003

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).

All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Posted

Number

Participants

From dosing change to end of follow-up (Week 73)(up to 48 weeks)

ID	Title	Description
OG000	Log Drop 0 to <1	All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
OG001	Log Drop 1 to <2	All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Posted

Number

Participants

From dosing change to end of follow-up (Week 73)(up to 48 weeks)

ID	Title	Description
OG000	Log Drop 1 to <2	Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
OG001	Log Drop 2 to <3	Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
OG002	Log Drop 3 to <4	Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.

Secondary

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.

Posted

Number

Participants

From dosing change to end of follow-up (Week 73) (up to 48 weeks)

ID	Title	Description
OG000	Log Drop <0	Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
OG001	Log Drop 0 to <1	Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
OG002	Log Drop 1 to <2	Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.

Primary

Percent of Participants Who Achieved Sustained Virologic Response (SVR)

SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.

All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.

For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.

Arm 1A was not analyzed.

For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.

Posted

Number

Percent of participants

Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

ID	Title	Description
OG000	Arm 1B: PEG + RBV + BOC 400	A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG001	Arm 2: PEG + BOC 100 (48 Weeks)	A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
OG002

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0020 events0 affected48 at risk EG0030 events0 affected49 at risk EG0040 events0 affected49 at risk EG0050 events0 affected97 at risk EG0060 events0 affected65 at risk EG0070 events0 affected143 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
ALCOHOLIC PANCREATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CHEST PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CHRONIC HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
MASTOIDITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
FOOD INTOLERANCE	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CERVICOBRACHIAL SYNDROME	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CONVULSION	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
RADIAL NERVE PALSY	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
ENDOMETRIOSIS	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
PROSTATITIS	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
LIVER TRANSPLANT	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0015 events4 affected34 at risk EG0021 events1 affected48 at risk EG0030 events0 affected49 at risk EG00412 events8 affected49 at risk EG0051 events1 affected97 at risk EG0062 events2 affected65 at risk EG00758 events54 affected143 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected15 at risk EG0013 events3 affected34 at risk EG0027 events5 affected48 at risk EG003
SPLENOMEGALY	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0023 events3 affected48 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
EAR DISCOMFORT	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0023 events3 affected48 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0024 events4 affected48 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0021 events1 affected48 at risk EG003
HYPERTHYROIDISM	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
DRY EYE	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
EYE IRRITATION	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
EYE PRURITUS	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0020 events0 affected48 at risk EG003
LACRIMATION INCREASED	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
VISION BLURRED	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0021 events1 affected48 at risk EG003
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0020 events0 affected48 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0024 events4 affected48 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0025 events4 affected48 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0014 events4 affected34 at risk EG00212 events9 affected48 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events6 affected15 at risk EG0018 events7 affected34 at risk EG00214 events11 affected48 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected34 at risk EG0020 events0 affected48 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected34 at risk EG0025 events5 affected48 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0022 events2 affected48 at risk EG003
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 events6 affected15 at risk EG00112 events9 affected34 at risk EG00217 events15 affected48 at risk EG003
ORAL MUCOSAL BLISTERING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0014 events4 affected34 at risk EG00210 events7 affected48 at risk EG003
ASTHENIA	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0019 events9 affected34 at risk EG0029 events8 affected48 at risk EG003
CHEST PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0021 events1 affected48 at risk EG003
CHILLS	General disorders	MedDRA 10.0	Systematic Assessment	EG0005 events4 affected15 at risk EG00116 events11 affected34 at risk EG00220 events19 affected48 at risk EG003
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment	EG00012 events10 affected15 at risk EG00116 events14 affected34 at risk EG00231 events25 affected48 at risk EG003
FEELING HOT	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0020 events0 affected48 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected15 at risk EG0016 events6 affected34 at risk EG0028 events7 affected48 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected15 at risk EG0014 events4 affected34 at risk EG00211 events10 affected48 at risk EG003
INJECTION SITE RASH	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
INJECTION SITE REACTION	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0016 events6 affected34 at risk EG0029 events9 affected48 at risk EG003
IRRITABILITY	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0019 events9 affected34 at risk EG0027 events7 affected48 at risk EG003
MALAISE	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events1 affected34 at risk EG0021 events1 affected48 at risk EG003
PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0016 events4 affected34 at risk EG0025 events4 affected48 at risk EG003
PYREXIA	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected15 at risk EG00115 events13 affected34 at risk EG00226 events19 affected48 at risk EG003
HEPATOMEGALY	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected34 at risk EG0024 events4 affected48 at risk EG003
SEASONAL ALLERGY	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
FOLLICULITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected34 at risk EG0020 events0 affected48 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0025 events3 affected48 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0024 events3 affected48 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0014 events4 affected34 at risk EG0021 events1 affected48 at risk EG003
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected34 at risk EG0026 events5 affected48 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0023 events3 affected48 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
VIRAL PHARYNGITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
SUNBURN	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0020 events0 affected48 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected34 at risk EG0026 events6 affected48 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected34 at risk EG0021 events1 affected48 at risk EG003
HYPERINSULINISM	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0022 events1 affected48 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0006 events5 affected15 at risk EG00110 events5 affected34 at risk EG00228 events17 affected48 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected15 at risk EG0013 events3 affected34 at risk EG0024 events4 affected48 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0025 events4 affected48 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 events6 affected15 at risk EG00110 events8 affected34 at risk EG00228 events23 affected48 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
APHASIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
BALANCE DISORDER	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected34 at risk EG0021 events1 affected48 at risk EG003
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0026 events5 affected48 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected15 at risk EG00110 events10 affected34 at risk EG00213 events10 affected48 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0014 events4 affected34 at risk EG0024 events3 affected48 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0009 events7 affected15 at risk EG00124 events20 affected34 at risk EG00239 events30 affected48 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0020 events0 affected48 at risk EG003
HYPOKINESIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
LETHARGY	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0023 events3 affected48 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected34 at risk EG0020 events0 affected48 at risk EG003
SPEECH DISORDER	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
TREMOR	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0014 events4 affected34 at risk EG0027 events6 affected48 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0005 events4 affected15 at risk EG0015 events4 affected34 at risk EG00213 events12 affected48 at risk EG003
INITIAL INSOMNIA	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected15 at risk EG00112 events9 affected34 at risk EG00214 events12 affected48 at risk EG003
MOOD SWINGS	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
NERVOUSNESS	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected34 at risk EG0024 events2 affected48 at risk EG003
SLEEP DISORDER	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
SEXUAL DYSFUNCTION	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected15 at risk EG00112 events7 affected34 at risk EG0029 events9 affected48 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected15 at risk EG0015 events4 affected34 at risk EG0029 events6 affected48 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected34 at risk EG0023 events2 affected48 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events1 affected15 at risk EG0013 events2 affected34 at risk EG0023 events3 affected48 at risk EG003
INCREASED UPPER AIRWAY SECRETION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0021 events1 affected48 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0023 events3 affected48 at risk EG003
NASAL DRYNESS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected34 at risk EG0026 events5 affected48 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected34 at risk EG0020 events0 affected48 at risk EG003
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected34 at risk EG0024 events4 affected48 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0016 events5 affected34 at risk EG00210 events10 affected48 at risk EG003
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0019 events9 affected34 at risk EG0027 events6 affected48 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected34 at risk EG0022 events2 affected48 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events3 affected34 at risk EG0023 events2 affected48 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0022 events2 affected48 at risk EG003
PALMAR ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
PHOTOSENSITIVITY REACTION	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0023 events2 affected48 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG00112 events9 affected34 at risk EG00210 events8 affected48 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0014 events4 affected34 at risk EG0025 events5 affected48 at risk EG003
SPIDER NAEVUS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0021 events1 affected48 at risk EG003
SWELLING FACE	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
CYST DRAINAGE	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected34 at risk EG0020 events0 affected48 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0011 events1 affected34 at risk EG0022 events2 affected48 at risk EG003

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C512204	N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
C417083	peginterferon alfa-2b
D012254	Ribavirin

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PEG + RBV	Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.	2	15	14	15
EG001	PEG + RBV + BOC 400 (24 Weeks)	Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	1	34	33	34
EG002	PEG + BOC 100 (48 Weeks)	Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	2	48	48	48
EG003	PEG + BOC 200 (48 Weeks)	Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	4	49	48	49
EG004	PEG + RBV + BOC 400 (48 Weeks)	Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	2	49	47	49
EG005	PEG + BOC 400 (24 + 48 Weeks)	Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	4	97	96	97
EG006	PEG + BOC 800 (24 Weeks)	Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.	3	65	64	65
EG007	PEG + RBV + BOC 800	Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.	12	143	136	143