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 1) (NCT NCT01343888)
NCT ID: NCT01343888
Last Updated: 2015-09-18
Results Overview
Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
656 participants
Primary outcome timeframe
12 weeks post treatment, up to 60 weeks
Results posted on
2015-09-18
Participant Flow
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Faldaprevir 120mg and PegIFN/RBV
Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
|
Faldaprevir 240mg and PegIFN/RBV
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
|
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Overall Study
STARTED
|
259
|
261
|
132
|
|
Overall Study
COMPLETED
|
234
|
222
|
110
|
|
Overall Study
NOT COMPLETED
|
25
|
39
|
22
|
Reasons for withdrawal
| Measure |
Faldaprevir 120mg and PegIFN/RBV
Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
|
Faldaprevir 240mg and PegIFN/RBV
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
|
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
22
|
5
|
|
Overall Study
Lack of Efficacy
|
9
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
2
|
|
Overall Study
other than stated above
|
0
|
0
|
1
|
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 1)
Baseline characteristics by cohort
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 11.44 • n=99 Participants
|
48.3 years
STANDARD_DEVIATION 11.89 • n=107 Participants
|
46.6 years
STANDARD_DEVIATION 12.53 • n=206 Participants
|
47.8 years
STANDARD_DEVIATION 11.85 • n=7 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
310 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
342 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
79.5 percentage of participants
Interval 74.6 to 84.4
|
80.5 percentage of participants
Interval 75.6 to 85.3
|
52.3 percentage of participants
Interval 43.8 to 60.8
|
SECONDARY outcome
Timeframe: 24 weeks post treatment, up to 72 weeksPopulation: 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.
Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Sustained Virological Response 24 Weeks Post-treatment (SVR24)
|
79.2 percentage of participants
Interval 74.2 to 84.1
|
79.7 percentage of participants
Interval 74.8 to 84.6
|
52.3 percentage of participants
Interval 43.8 to 60.8
|
SECONDARY outcome
Timeframe: week 4 and week 8Population: 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.
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
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Early Treatment Success (ETS)
|
87.3 percentage of participants
|
89.3 percentage of participants
|
22.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes, BL elevated to EoT normal
|
97 participants
|
115 participants
|
31 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes
|
206 participants
|
210 participants
|
69 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes, BL normal to EoT normal
|
66 participants
|
68 participants
|
27 participants
|
|
Alanine Aminotransferase (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 weeksPopulation: 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.
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
SVR12 = No, BL normal to EoT normal
|
15 participants
|
10 participants
|
15 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
SVR12 = No, BL elevated to EoT normal
|
16 participants
|
22 participants
|
20 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
SVR12 = No, No ALT data available at EoT
|
0 participants
|
0 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
SVR12 = No
|
53 participants
|
51 participants
|
63 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes
|
206 participants
|
210 participants
|
69 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, BL normal to SVR12 normal
|
72 participants
|
73 participants
|
27 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, BL elevated to SVR12 normal
|
125 participants
|
126 participants
|
39 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, No ALT data available post-treatment
|
4 participants
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, No ALT data available post-treatment
|
8 participants
|
14 participants
|
45 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No
|
53 participants
|
51 participants
|
63 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, BL normal to SVR12 normal
|
9 participants
|
5 participants
|
5 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, BL elevated to SVR12 normal
|
6 participants
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Aspartate Aminotransferase (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
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes
|
206 participants
|
210 participants
|
69 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes, BL normal to EoT normal
|
95 participants
|
99 participants
|
34 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
SVR12 = Yes, BL elevated to EoT normal
|
74 participants
|
76 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
SVR12 = No
|
53 participants
|
51 participants
|
63 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
SVR12 = No, No AST data available at EoT
|
0 participants
|
0 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
SVR12 = No, BL normal to EoT normal
|
17 participants
|
16 participants
|
21 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
SVR12 = No, BL elevated to EoT normal
|
14 participants
|
16 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes
|
206 participants
|
210 participants
|
69 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, No AST data available post-treatment
|
5 participants
|
5 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, BL normal to SVR12 normal
|
102 participants
|
109 participants
|
39 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12 = Yes, BL elevated to SVR12 normal
|
90 participants
|
88 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment, up to 60 weeksPopulation: 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.
This will be presented as the number of patients. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 Participants
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 Participants
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 Participants
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No
|
53 participants
|
51 participants
|
63 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, BL normal to SVR12 normal
|
10 participants
|
10 participants
|
5 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, BL elevated to SVR12 normal
|
10 participants
|
5 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12 = No, No AST data available post-treatment
|
8 participants
|
14 participants
|
45 participants
|
Adverse Events
Faldaprevir 120mg and PegIFN/RBV
Serious events: 17 serious events
Other events: 246 other events
Deaths: 0 deaths
Faldaprevir 240mg and PegIFN/RBV
Serious events: 17 serious events
Other events: 250 other events
Deaths: 0 deaths
Placebo and PegIFN/RBV
Serious events: 8 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Faldaprevir 120mg and PegIFN/RBV
n=259 participants at risk
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 participants at risk
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 participants at risk
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
0.77%
2/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Histiocytosis haematophagic
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Idiopathic thrombocytopenic purpura
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Leukopenia
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Atrial fibrillation
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Myocardial infarction
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Retinopathy
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Haemorrhoids
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Inguinal hernia
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
0.77%
2/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Chest pain
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 lesion
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Sarcoidosis
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Bronchopneumonia
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Urinary tract infection
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Gun shot wound
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Subdural haematoma
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Diabetes mellitus
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Muscular weakness
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Polymyositis
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Cerebrovascular accident
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Cubital tunnel syndrome
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Sciatica
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Psychotic disorder
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
1/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Vascular disorders
Hypotension
|
0.39%
1/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
0/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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=259 participants at risk
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
|
Faldaprevir 240mg and PegIFN/RBV
n=261 participants at risk
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
|
Placebo and PegIFN/RBV
n=132 participants at risk
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.8%
46/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
16.5%
43/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
12.4%
32/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
9.6%
25/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
13.6%
18/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
4.2%
11/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
15/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
6.9%
18/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
9.2%
24/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
4.2%
11/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
16/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.8%
5/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
20.5%
53/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
26.1%
68/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
12.9%
17/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
3.1%
8/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
6/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
4.6%
12/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
5.4%
14/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
28.2%
73/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
36.4%
95/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
19/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Stomatitis
|
4.6%
12/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
4.2%
11/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
10.8%
28/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
19.9%
52/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
20.5%
53/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
16.5%
43/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
25.5%
66/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
29.5%
77/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
26.5%
35/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
15.4%
40/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
19.9%
52/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
15.9%
21/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Irritability
|
7.3%
19/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
6.9%
18/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
7.7%
20/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
16/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
12/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
22.0%
57/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
20.3%
53/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
24.2%
32/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
1.5%
4/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
5.4%
14/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
6.6%
17/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
18.4%
48/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Nasopharyngitis
|
5.4%
14/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
16/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Haemoglobin decreased
|
5.8%
15/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
5/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
5.0%
13/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
15/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
13.5%
35/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
19.9%
52/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
7.3%
19/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
7.7%
20/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
5.4%
14/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.1%
8/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
8.5%
22/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
7.3%
19/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
3.9%
10/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.1%
8/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
6.6%
17/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
8.0%
21/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
9.8%
13/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
29.3%
76/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
26.8%
70/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
30.3%
40/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
7.7%
20/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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%
12/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
14.7%
38/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
12.3%
32/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
Sleep disorder
|
4.6%
12/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
5.4%
14/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.8%
5/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.6%
30/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
10.7%
28/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.6%
17/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
7.3%
19/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
12.1%
16/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.2%
42/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
18.0%
47/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
35/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
17.2%
45/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
12.9%
17/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.5%
9/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
6.9%
18/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.7%
82/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
29.9%
78/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
31.1%
41/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.6%
69/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
26.8%
70/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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
|
5.0%
13/259 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.8%
10/261 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
3.8%
5/132 • The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
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.
|
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 Other - 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