Trial Outcomes & Findings for IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (NCT NCT01732796)
NCT ID: NCT01732796
Last Updated: 2016-04-18
Results Overview
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
470 participants
Primary outcome timeframe
12 Week (post-treatment)
Results posted on
2016-04-18
Participant Flow
It was planned that approximately 800 patients would be screened in order to randomize and treat approximately 460 patients (195 patients in treatment Groups 1 and 2 each, 40-70 patients in treatment Group 3).
Treatment-naïve patients with chronic hepatitis C infection of genotype (GT)1b were included in the trial. Patients with compensated liver cirrhosis, defined as Ishak Grade ≥5 or METAVIR Grade ≥4 on liver biopsy, or liver stiffness of ≥ 13 kilopascal (kPa) on fibroscan, were assigned to Group 3.
Participant milestones
| Measure |
16 wk NC FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk NC FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk CR FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
208
|
211
|
51
|
|
Overall Study
COMPLETED
|
162
|
169
|
38
|
|
Overall Study
NOT COMPLETED
|
46
|
42
|
13
|
Reasons for withdrawal
| Measure |
16 wk NC FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk NC FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk CR FDV+DBV+RBV
600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
16
|
16
|
4
|
|
Overall Study
Lack of Efficacy
|
21
|
18
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
2
|
|
Overall Study
Other reason not defined above
|
1
|
0
|
2
|
Baseline Characteristics
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Baseline characteristics by cohort
| Measure |
16 wk NC FDV+DBV+RBV
n=208 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk NC FDV+DBV+RBV
n=211 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
|
24 wk CR FDV+DBV+RBV
n=51 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.1 Years
STANDARD_DEVIATION 12.7 • n=93 Participants
|
51.1 Years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
57.9 Years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
51.4 Years
STANDARD_DEVIATION 12.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
254 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
216 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 Week (post-treatment)Population: The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Outcome measures
| Measure |
24 wk FDV+DBV+RBV
n=262 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
|
16 wk FDV+DBV+RBV
n=259 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
|
24 wk CR FDV+DBV+RBV
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
SVR12 Rates With Historical Control
non-cirrhotic (N=174, 149)
|
82.5 Percentage of participants
|
71.6 Percentage of participants
|
—
|
|
SVR12 Rates With Historical Control
cirrhotic (N=37, 37)
|
72.5 Percentage of participants
|
72.5 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 12 Week (post-treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Outcome measures
| Measure |
24 wk FDV+DBV+RBV
n=208 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
|
16 wk FDV+DBV+RBV
n=211 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
|
24 wk CR FDV+DBV+RBV
n=51 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
Comparisons of SVR12 Rates Across Treatment Arms
|
71.6 Percentage of participants
|
82.5 Percentage of participants
|
72.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 4 Week (post-treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
Outcome measures
| Measure |
24 wk FDV+DBV+RBV
n=208 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
|
16 wk FDV+DBV+RBV
n=211 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
|
24 wk CR FDV+DBV+RBV
n=51 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
SVR4
Percentage of patients with response
|
78.4 Percentage of participants
|
84.4 Percentage of participants
|
76.5 Percentage of participants
|
|
SVR4
Positive predicted value
|
94.0 Percentage of participants
|
98.0 Percentage of participants
|
95.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 Week (post-treatment)Population: FAS
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
Outcome measures
| Measure |
24 wk FDV+DBV+RBV
n=208 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
|
16 wk FDV+DBV+RBV
n=211 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
|
24 wk CR FDV+DBV+RBV
n=51 Participants
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
SVR24
Percentage of patients with response
|
70.7 Percantage of participants
|
80.6 Percantage of participants
|
72.5 Percantage of participants
|
|
SVR24
Positive predicted value
|
97.0 Percantage of participants
|
99.0 Percantage of participants
|
100.0 Percantage of participants
|
Adverse Events
16 wk NC FDV+DBV+RBV
Serious events: 7 serious events
Other events: 192 other events
Deaths: 0 deaths
24 wk NC FDV+DBV+RBV
Serious events: 11 serious events
Other events: 198 other events
Deaths: 0 deaths
24 wk CR FDV+DBV+RBV
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
16 wk NC FDV+DBV+RBV
n=208 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk NC FDV+DBV+RBV
n=211 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
|
24 wk CR FDV+DBV+RBV
n=51 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.95%
2/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Cardiac disorders
Pericarditis
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Fatigue
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Pyrexia
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Infections and infestations
Gastritis bacterial
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Injury, poisoning and procedural complications
Dumping syndrome
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Dizziness
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Loss of consciousness
|
0.48%
1/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Syncope
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Depression
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Vascular disorders
Haematoma
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.47%
1/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
0.00%
0/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
Other adverse events
| Measure |
16 wk NC FDV+DBV+RBV
n=208 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).
This group included non-cirrhotic patients (NC).
|
24 wk NC FDV+DBV+RBV
n=211 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
|
24 wk CR FDV+DBV+RBV
n=51 participants at risk
600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.2%
40/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
25.1%
53/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
37.3%
19/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Eye disorders
Ocular icterus
|
9.6%
20/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.1%
15/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
14/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
4.7%
10/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
14/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.6%
16/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.0%
25/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
12.8%
27/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.9%
2/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
12/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
6.6%
14/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.0%
50/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
31.3%
66/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
33.3%
17/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
24/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
11.8%
25/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.8%
5/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
96/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
53.1%
112/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
52.9%
27/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
64/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
29.4%
62/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
35.3%
18/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Asthenia
|
19.2%
40/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
27.5%
58/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
13.7%
7/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Chest pain
|
2.4%
5/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
1.4%
3/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Chills
|
2.4%
5/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
1.4%
3/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Fatigue
|
25.5%
53/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
23.7%
50/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
25.5%
13/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
General disorders
Pyrexia
|
2.9%
6/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.8%
6/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.2%
17/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.1%
17/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.8%
5/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Hepatobiliary disorders
Jaundice
|
13.5%
28/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
16.6%
35/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
19.6%
10/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
12/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
6.2%
13/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Injury, poisoning and procedural complications
Sunburn
|
4.3%
9/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.1%
17/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Investigations
Blood bilirubin increased
|
3.8%
8/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
4.7%
10/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.8%
5/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Investigations
Weight decreased
|
6.2%
13/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.0%
19/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.8%
5/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.6%
20/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
15.6%
33/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
11.8%
6/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
14/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
10.0%
21/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
13/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.2%
11/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
13/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.8%
6/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Dizziness
|
6.2%
13/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.5%
18/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
9.8%
5/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
11/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.8%
8/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Headache
|
15.9%
33/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
14.2%
30/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
11/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.1%
17/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.9%
2/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Nervous system disorders
Syncope
|
0.00%
0/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.8%
8/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
5.9%
3/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Depression
|
5.3%
11/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.5%
18/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
2.0%
1/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Insomnia
|
8.2%
17/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
13.7%
29/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
19.6%
10/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Psychiatric disorders
Irritability
|
2.9%
6/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
6.6%
14/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.9%
2/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
13/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.1%
17/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
13.7%
7/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
14/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
8.5%
18/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
7.8%
4/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
18/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
4.3%
9/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.9%
2/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.7%
18/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
6.2%
13/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
3.9%
2/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
23/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
13.3%
28/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
15.7%
8/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
13.9%
29/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
14.2%
30/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
19.6%
10/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
38/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
25.1%
53/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
39.2%
20/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.8%
35/208 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
17.5%
37/211 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
21.6%
11/51 • From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).
Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER