Trial Outcomes & Findings for Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2) (NCT NCT01297270)

Last Updated: 2015-09-18

Results Overview

Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level\<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

658 participants

Primary outcome timeframe

12 weeks post treatment, up to 60 weeks

Results posted on

2015-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Faldaprevir 120mg and PegIFN/RBV Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Placebo and PegIFN/RBV Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Study STARTED	262	264	132
Overall Study COMPLETED	217	192	103
Overall Study NOT COMPLETED	45	72	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Faldaprevir 120mg and PegIFN/RBV Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Placebo and PegIFN/RBV Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Study Adverse Event	19	32	5
Overall Study Lack of Efficacy	15	17	15
Overall Study Lost to Follow-up	1	2	1
Overall Study Protocol Violation	0	2	0
Overall Study Withdrawal by Subject	7	15	7
Overall Study Other reason not defined above	3	3	1
Overall Study Not treated	0	1	0

Baseline Characteristics

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Total n=657 Participants Total of all reporting groups	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Age, Continuous	50.2 years STANDARD_DEVIATION 8.78 • n=27 Participants	50.3 years STANDARD_DEVIATION 9.53 • n=483 Participants	50.2 years STANDARD_DEVIATION 10.05 • n=93 Participants	50.4 years STANDARD_DEVIATION 9.40 • n=4 Participants
Sex: Female, Male Female	54 Participants n=27 Participants	268 Participants n=483 Participants	105 Participants n=93 Participants	109 Participants n=4 Participants
Sex: Female, Male Male	78 Participants n=27 Participants	389 Participants n=483 Participants	157 Participants n=93 Participants	154 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	47.0 percentage of participants Interval 38.5 to 55.5	67.9 percentage of participants Interval 62.3 to 73.6	64.3 percentage of participants Interval 58.5 to 70.1

SECONDARY outcome

Timeframe: 24 weeks post treatment, up to 72 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA)

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)	46.2 percentage of participants Interval 37.7 to 54.7	67.2 percentage of participants Interval 61.5 to 72.9	62.7 percentage of participants Interval 56.9 to 68.6

SECONDARY outcome

Timeframe: Week 4 and week 8

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level \<25 IU/mL (detected or undetected) at week 4 and HCV RNA \<25 IU/mL (undetected) at week 8.

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Early Treatment Success (ETS)	15.9 percentage of participants	80.2 percentage of participants	79.1 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes	62 participants	178 participants	169 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, BL normal to EOT normal	22 participants	50 participants	52 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, BL elevated to EOT normal	35 participants	89 participants	81 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, No ALT data available at EoT	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO SVR12 = No	70 participants	84 participants	94 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO SVR12 = No, BL normal to EOT normal	15 participants	21 participants	20 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO SVR12 = No, BL elevated to EOT normal	30 participants	33 participants	44 participants
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO SVR12 = No, No ALT data available at EoT	1 participants	3 participants	5 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes	62 participants	178 participants	169 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, BL normal to SVR12 normal	23 participants	52 participants	58 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, BL elevated to SVR12 normal	37 participants	105 participants	100 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, No ALT data available at SVR12 visit	0 participants	9 participants	3 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No	70 participants	84 participants	94 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, BL normal to SVR12 normal	3 participants	12 participants	11 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, BL elevated to SVR12 normal	2 participants	13 participants	16 participants
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, No ALT data available at SVR12 visit	54 participants	23 participants	34 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes	62 participants	178 participants	169 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, BL normal to EOT normal	26 participants	70 participants	78 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, BL elevated to EOT normal	26 participants	65 participants	51 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES SVR12 = Yes, No AST data available at EoT	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO SVR12 = No	70 participants	84 participants	94 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO SVR12 = No, BL normal to EOT normal	17 participants	27 participants	24 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO SVR12 = No, BL elevated to EOT normal	26 participants	27 participants	33 participants
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO SVR12 = No, No AST data available at EoT	1 participants	3 participants	5 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes	62 participants	178 participants	169 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, BL normal to SVR12 normal	29 participants	71 participants	84 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, BL elevated to SVR12 normal	30 participants	86 participants	71 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES SVR12 = Yes, No AST data available at SVR12 visit	0 participants	9 participants	3 participants

SECONDARY outcome

Timeframe: 12 weeks post treatment, up to 60 weeks

Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Outcome measures

Outcome measures
Measure	Placebo and PegIFN/RBV n=132 Participants Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	Faldaprevir 120mg and PegIFN/RBV n=262 Participants Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 Participants Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No	70 participants	84 participants	94 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, BL normal to SVR12 normal	3 participants	13 participants	11 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, BL elevated to SVR12 normal	1 participants	15 participants	12 participants
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO SVR12 = No, No AST data available at SVR12 visit	54 participants	23 participants	34 participants

Adverse Events

Faldaprevir 120mg and PegIFN/RBV

Serious events: 21 serious events

Other events: 255 other events

Deaths: 0 deaths

Faldaprevir 240mg and PegIFN/RBV

Serious events: 26 serious events

Other events: 258 other events

Deaths: 0 deaths

Placebo and PegIFN/RBV

Serious events: 8 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Faldaprevir 120mg and PegIFN/RBV n=262 participants at risk Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 participants at risk Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Placebo and PegIFN/RBV n=132 participants at risk Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Blood and lymphatic system disorders Anaemia	0.76% 2/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Blood and lymphatic system disorders Neutropenia	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Cardiac disorders Acute myocardial infarction	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Cardiac disorders Angina pectoris	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Congenital, familial and genetic disorders Epidermolysis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Eye disorders Optic ischaemic neuropathy	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Ascites	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Diarrhoea	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 2/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Large intestine perforation	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Nausea	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 2/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Pancreatitis	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Umbilical hernia	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Vomiting	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	1.1% 3/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Malaise	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Bile duct stone	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Cholecystitis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Hepatic cirrhosis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Hepatic failure	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 2/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Immune system disorders Hypersensitivity	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Cellulitis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Diverticulitis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Infective chondritis	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Pneumonia	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Sepsis	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Subcutaneous abscess	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Vulval abscess	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Contusion	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Fibula fracture	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Jaw fracture	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Laceration	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Injury, poisoning and procedural complications Tibia fracture	0.38% 1/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Metabolism and nutrition disorders Dehydration	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.38% 1/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.

Other adverse events
Measure	Faldaprevir 120mg and PegIFN/RBV n=262 participants at risk Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Faldaprevir 240mg and PegIFN/RBV n=263 participants at risk Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	Placebo and PegIFN/RBV n=132 participants at risk Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Blood and lymphatic system disorders Anaemia	22.5% 59/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	20.9% 55/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	20.5% 27/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Blood and lymphatic system disorders Neutropenia	13.4% 35/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	9.1% 24/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	10.6% 14/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 13/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.3% 11/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Eye disorders Ocular icterus	1.1% 3/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.76% 1/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Abdominal pain	7.6% 20/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.7% 23/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	7.6% 10/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Abdominal pain upper	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	3.0% 8/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.8% 9/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Constipation	8.4% 22/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 7/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Diarrhoea	27.1% 71/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	33.8% 89/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	17.4% 23/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Dry mouth	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.1% 16/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	4.5% 6/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Dyspepsia	9.9% 26/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.5% 17/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	2.3% 3/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Nausea	37.8% 99/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	57.0% 150/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	39.4% 52/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Gastrointestinal disorders Vomiting	15.3% 40/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	26.6% 70/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.3% 11/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Asthenia	3.8% 10/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	7.2% 19/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	4.5% 6/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Chills	15.3% 40/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	14.4% 38/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	18.9% 25/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Fatigue	43.1% 113/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	50.6% 133/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	53.0% 70/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Influenza like illness	9.5% 25/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	11.4% 15/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Injection site erythema	5.0% 13/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	4.9% 13/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.3% 11/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Injection site reaction	9.9% 26/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	4.9% 13/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	3.0% 4/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Pain	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.4% 22/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.8% 9/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
General disorders Pyrexia	14.5% 38/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	15.6% 41/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	15.2% 20/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Hyperbilirubinaemia	3.1% 8/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	9.5% 25/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Hepatobiliary disorders Jaundice	2.3% 6/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	9.1% 24/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	0.00% 0/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Bronchitis	1.9% 5/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	1.5% 2/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Infections and infestations Upper respiratory tract infection	6.9% 18/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	7.2% 19/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.8% 9/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Investigations Weight decreased	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	7.6% 20/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	7.6% 10/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Metabolism and nutrition disorders Decreased appetite	20.6% 54/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	24.0% 63/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	19.7% 26/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Musculoskeletal and connective tissue disorders Arthralgia	13.7% 36/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	13.7% 36/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	16.7% 22/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Musculoskeletal and connective tissue disorders Back pain	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.1% 16/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.3% 11/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Musculoskeletal and connective tissue disorders Muscle spasms	0.76% 2/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	3.0% 8/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 7/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Musculoskeletal and connective tissue disorders Myalgia	17.9% 47/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	20.2% 53/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	28.0% 37/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Musculoskeletal and connective tissue disorders Pain in extremity	4.2% 11/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	4.6% 12/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.1% 8/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Nervous system disorders Disturbance in attention	3.4% 9/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 14/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	6.1% 8/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Nervous system disorders Dizziness	15.6% 41/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	14.8% 39/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	18.9% 25/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Nervous system disorders Dysgeusia	6.1% 16/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.7% 15/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	2.3% 3/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Nervous system disorders Headache	32.1% 84/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	30.8% 81/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	34.1% 45/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Nervous system disorders Hypoaesthesia	3.1% 8/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	1.9% 5/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	5.3% 7/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Psychiatric disorders Anxiety	5.7% 15/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	9.5% 25/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	10.6% 14/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Psychiatric disorders Depression	12.2% 32/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	13.7% 36/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	8.3% 11/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Psychiatric disorders Insomnia	27.1% 71/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	25.1% 66/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	28.8% 38/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.
Psychiatric disorders Irritability	13.4% 35/262 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	12.2% 32/263 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.	20.5% 27/132 • Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment) Adverse events (AEs) that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization \[safety set (SAF)\] were included in the presentation of AE data.