Trial Outcomes & Findings for A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) (NCT NCT01447420)

Last Updated: 2016-07-25

Results Overview

Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

129 participants

Primary outcome timeframe

At Week 72

Results posted on

2016-07-25

Participant Flow

A total of 129 participants were enrolled from February 2011 to November 2012 at 14 study sites in Brazil.

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Overall Study STARTED	39	72	18
Overall Study COMPLETED	29	45	8
Overall Study NOT COMPLETED	10	27	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Overall Study Adverse Event	2	4	2
Overall Study Protocol Violation	3	3	0
Overall Study Withdrawal by Subject	4	1	0
Overall Study Lack of Efficacy	1	19	8

Baseline Characteristics

A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=39 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT n=72 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT n=18 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Total n=129 Participants Total of all reporting groups
Age, Continuous	48.51 years STANDARD_DEVIATION 12.71 • n=5 Participants	50.43 years STANDARD_DEVIATION 10.92 • n=7 Participants	52.33 years STANDARD_DEVIATION 10.22 • n=5 Participants	50.12 years STANDARD_DEVIATION 11.38 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	33 Participants n=7 Participants	9 Participants n=5 Participants	64 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	39 Participants n=7 Participants	9 Participants n=5 Participants	65 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 72

Population: The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=38 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT n=72 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT n=18 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression	63.2 Percentage of participants Interval 46.0 to 78.2	26.4 Percentage of participants Interval 16.7 to 38.1	33.3 Percentage of participants Interval 13.3 to 59.0

PRIMARY outcome

Timeframe: Up to Week 72

Population: Safety population included all enrolled participants who received at least one dose of any study medication.

Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \< 11 gram per decilitre (g/dL) for women and Hb \< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=129 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Percentage of Participants With Incidence of Anemia	67.4 Percentage of participants Interval 58.6 to 75.4	—	—

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 48, 60 and 72

Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a \>= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=38 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT n=72 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT n=18 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression RVR rate, Week 4 (n = 14)	11 participants	3 participants	0 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression pEVR rate, Week 12 (n = 33)	4 participants	24 participants	5 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression cEVR rate, Week 12 (n = 72)	31 participants	36 participants	5 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression VR rate, Week 24 (n = 87)	31 participants	46 participants	10 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression VR rate, EOT (Week 48) (n = 74)	28 participants	37 participants	9 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression VR rate, 12 weeks post-treatment (n = 50)	25 participants	19 participants	6 participants
Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression SVR rate, 24 weeks or more post-treatment (n = 49)	24 participants	19 participants	6 participants

SECONDARY outcome

Timeframe: Up to Week 72

Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=38 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT n=72 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT n=18 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment SVR with No anemia (n = 15, 20, 6)	9 participants	4 participants	2 participants
Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment In the first month of treatment (n = 10, 15, 2)	6 participants	3 participants	0 participants
Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment After the first month of treatment (n = 13, 37,10)	9 participants	12 participants	4 participants

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 12

Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: \< 1.0 log IU/ml; \>= 1.0 and \< 2.0 log IU/ml; \>= 2.0 and \< 3.0 log IU/ml; \>= 3.0 and \<4.0 log IU/ml; \>= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10\^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC n=35 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\<) 75 kg and 1,200 mg per day for greater than or equal to \[\>=\] 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT n=69 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).	Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT n=18 Participants Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \< 75 kg and 1,200 mg per day for \>= 75 kg).
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 4 (<1.0 log10 UI / ml)	0 participants	26 participants	10 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 4 (>=1.0 e < 2.0 log10 UI / ml)	4 participants	24 participants	5 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 4 (>=2.0 e < 3.0 log10 UI / ml)	9 participants	13 participants	1 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 4 (>=3.0 e < 4.0 log10 UI / ml)	13 participants	2 participants	1 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 4 (>=4.0 log10 UI / ml)	8 participants	3 participants	0 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 12 (<1.0 log10 UI / ml)	0 participants	1 participants	3 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 12 (>=1.0 e < 2.0 log10 UI / ml)	3 participants	9 participants	5 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 12 (>=2.0 e < 3.0 log10 UI / ml)	5 participants	11 participants	3 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 12 (>=3.0 e < 4.0 log10 UI / ml)	5 participants	22 participants	3 participants
Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 Week 0 - Week 12 (>=4.0 log10 UI / ml)	22 participants	26 participants	4 participants

Adverse Events

Peginterferon Alfa-2a Plus Ribavirin

Serious events: 6 serious events

Other events: 125 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peginterferon Alfa-2a Plus Ribavirin n=129 participants at risk Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for \< 75 kg and 1200 mg per day for \>= 75 kg, orally daily, 48 weeks.
Eye disorders Retinal vascular disorder	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Perianal erythema	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Nervous system disorders Hepatic encephalopathy	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Psychiatric disorders Anxiety disorder	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Cardiac disorders Chest pain	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Eye disorders Optic ischaemic neuropathy	0.78% 1/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.

Other adverse events

Other adverse events
Measure	Peginterferon Alfa-2a Plus Ribavirin n=129 participants at risk Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for \< 75 kg and 1200 mg per day for \>= 75 kg, orally daily, 48 weeks.
Blood and lymphatic system disorders Anaemia	31.8% 41/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Blood and lymphatic system disorders Neutropenia	17.8% 23/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Blood and lymphatic system disorders Thrombocytopenia	8.5% 11/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Cardiac disorders Dizziness	11.6% 15/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Eye disorders Eye pain	7.0% 9/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Nausea	24.8% 32/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Diarrhoea	19.4% 25/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Dyspepsia	12.4% 16/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Abdominal pain	11.6% 15/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Upper abdominal pain	10.9% 14/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Vomiting	7.8% 10/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Gastrointestinal disorders Aphthous stomatitis	6.2% 8/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
General disorders Pyrexia	37.2% 48/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
General disorders Asthenia	27.1% 35/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
General disorders Fatigue	15.5% 20/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
General disorders Discomfort	13.2% 17/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
General disorders Pain	11.6% 15/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Infections and infestations Influenza	41.9% 54/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Metabolism and nutrition disorders Decreased appetite	17.8% 23/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Musculoskeletal and connective tissue disorders Myalgia	32.6% 42/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Musculoskeletal and connective tissue disorders Chills	14.7% 19/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Musculoskeletal and connective tissue disorders Back pain	9.3% 12/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 10/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Nervous system disorders Headache	42.6% 55/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Psychiatric disorders Insomnia	19.4% 25/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Psychiatric disorders Irritability	19.4% 25/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Psychiatric disorders Depression	5.4% 7/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Renal and urinary disorders Urinary tract infection	5.4% 7/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Respiratory, thoracic and mediastinal disorders Cough	14.7% 19/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.4% 7/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Skin and subcutaneous tissue disorders Pruritus	19.4% 25/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Skin and subcutaneous tissue disorders Alopecia	7.0% 9/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Skin and subcutaneous tissue disorders Pruritus generalised	6.2% 8/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Skin and subcutaneous tissue disorders Rash	6.2% 8/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Vascular disorders Epistaxis	5.4% 7/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.
Vascular disorders Hypertension	5.4% 7/129 • Up to Week 72 Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER