Trial Outcomes & Findings for Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C (NCT NCT00336479)
NCT ID: NCT00336479
Last Updated: 2014-07-23
Results Overview
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
24 weeks after the completion of study drug dosing (up to Week 72)
Results posted on
2014-07-23
Participant Flow
A total of 263 subjects were enrolled, of which 13 subjects discontinued the study prior to study drug administration. A total of 250 subjects started treatment.
Participant milestones
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
79
|
79
|
17
|
|
Overall Study
COMPLETED
|
38
|
54
|
53
|
13
|
|
Overall Study
NOT COMPLETED
|
37
|
25
|
26
|
4
|
Reasons for withdrawal
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
11
|
18
|
4
|
|
Overall Study
Noncompliant
|
1
|
7
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
|
Overall Study
Virologic Stopping Rule
|
20
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Baseline characteristics by cohort
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
250 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
48.1 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Region of Enrollment
North America
|
75 participants
n=5 Participants
|
79 participants
n=7 Participants
|
79 participants
n=5 Participants
|
17 participants
n=4 Participants
|
250 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after the completion of study drug dosing (up to Week 72)Population: The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
|
41.3 percentage of participants
Interval 30.0 to 53.0
|
67.1 percentage of participants
Interval 56.0 to 77.0
|
60.8 percentage of participants
Interval 49.0 to 72.0
|
35.3 percentage of participants
Interval 14.0 to 62.0
|
SECONDARY outcome
Timeframe: 12 weeks after the completion of study drug dosing (up to Week 60)Population: The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
|
36.0 percentage of participants
Interval 25.0 to 48.0
|
58.2 percentage of participants
Interval 47.0 to 69.0
|
53.2 percentage of participants
Interval 42.0 to 64.0
|
35.3 percentage of participants
Interval 14.0 to 62.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
75 participants
|
79 participants
|
79 participants
|
17 participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
4 participants
|
5 participants
|
10 participants
|
3 participants
|
SECONDARY outcome
Timeframe: After last dose of study drug up to antiviral follow-up (up to Week 72)Population: Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=35 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=51 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=41 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=9 Participants
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Number of Subjects With Viral Relapse
|
8 participants
|
3 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85Population: Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=175 Participants
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cmax
|
3032.48 nanogram per milliliter (ng/mL)
Standard Deviation 756.93
|
—
|
—
|
—
|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cmin
|
2235.51 nanogram per milliliter (ng/mL)
Standard Deviation 618.37
|
—
|
—
|
—
|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Cavg
|
2738.46 nanogram per milliliter (ng/mL)
Standard Deviation 699.06
|
—
|
—
|
—
|
Adverse Events
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Serious events: 5 serious events
Other events: 79 other events
Deaths: 0 deaths
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Serious events: 10 serious events
Other events: 79 other events
Deaths: 0 deaths
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 participants at risk
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
LOBAR PNEUMONIA
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
ANXIETY
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
SCOTOMA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
RETINAL EXUDATES
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
RETINAL INFARCTION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Endocrine disorders
ADRENAL DISORDER
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Other adverse events
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=75 participants at risk
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
n=79 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
|
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
n=79 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
n=17 participants at risk
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
ECZEMA ASTEATOTIC
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
FATIGUE
|
76.0%
57/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
73.4%
58/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
69.6%
55/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
82.4%
14/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
42.7%
32/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
38.0%
30/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
49.4%
39/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.3%
6/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
24.0%
18/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
31.6%
25/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
27.8%
22/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.3%
6/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
PYREXIA
|
29.3%
22/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.0%
15/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.3%
16/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
IRRITABILITY
|
29.3%
22/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.5%
13/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
CHILLS
|
18.7%
14/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
22.8%
18/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
PAIN
|
20.0%
15/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.4%
9/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
PHARMACEUTICAL PRODUCT COMPLAINT
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
FEELING HOT
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
MALAISE
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
22.7%
17/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
40.5%
32/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
48.1%
38/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.5%
4/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH
|
26.7%
20/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
40.5%
32/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
30.4%
24/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.3%
6/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
25.3%
19/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.5%
13/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.7%
14/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.4%
9/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
22.8%
18/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
10.7%
8/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.5%
13/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.7%
14/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
HYPOTRICHOSIS
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
10.7%
8/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
STASIS DERMATITIS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
NAUSEA
|
29.3%
22/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
48.1%
38/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
55.7%
44/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
64.7%
11/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
DIARRHOEA
|
28.0%
21/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
34.2%
27/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
41.8%
33/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.5%
4/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
VOMITING
|
12.0%
9/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.3%
16/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
24.1%
19/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.5%
13/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.7%
10/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.5%
4/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.9%
7/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.7%
5/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.0%
6/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
5/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
8.0%
6/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
FLATULENCE
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
ANAL DISCOMFORT
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
8.0%
6/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
PAINFUL DEFAECATION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
PRURITUS ANI
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
LOOSE TOOTH
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
HEADACHE
|
60.0%
45/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
43.0%
34/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
46.8%
37/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
52.9%
9/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
DIZZINESS
|
18.7%
14/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.0%
15/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
27.8%
22/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.5%
4/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
DYSGEUSIA
|
10.7%
8/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.9%
7/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
TREMOR
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
HYPOAESTHESIA
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
PARAESTHESIA
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
SOMNOLENCE
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
PAROSMIA
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
POOR QUALITY SLEEP
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
MENTAL IMPAIRMENT
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
INSOMNIA
|
38.7%
29/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
34.2%
27/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
44.3%
35/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.3%
6/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
DEPRESSION
|
17.3%
13/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.0%
15/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.5%
17/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
ANXIETY
|
17.3%
13/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.9%
11/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
MOOD SWINGS
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
LIBIDO DECREASED
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
TEARFULNESS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
21.3%
16/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.5%
17/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.5%
13/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
23.5%
4/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
24.0%
18/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
19.0%
15/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.4%
9/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.0%
12/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.7%
5/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.9%
7/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.1%
8/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.7%
14/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.3%
16/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.5%
17/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.7%
11/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.7%
10/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.2%
12/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
10.7%
8/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
10.7%
8/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.7%
5/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
6.7%
5/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
26.7%
20/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
29.1%
23/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.7%
29/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.3%
6/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
24.0%
18/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
24.1%
19/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.9%
11/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
SINUSITIS
|
9.3%
7/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
VISION BLURRED
|
8.0%
6/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.7%
14/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.7%
10/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.6%
3/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
DRY EYE
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
PHOTOPHOBIA
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
CONJUNCTIVITIS
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
11.8%
2/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
EYE PRURITUS
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
VITREOUS FLOATERS
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
OCULAR ICTERUS
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
SCOTOMA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
CATARACT
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
RETINAL EXUDATES
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
12.0%
9/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.9%
11/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.7%
10/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.1%
4/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
TINNITUS
|
5.3%
4/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.6%
6/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
VERTIGO
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
POLLAKIURIA
|
2.7%
2/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.8%
3/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.3%
5/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
CONTACT LENS COMPLICATION
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
FLUSHING
|
1.3%
1/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.3%
1/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
PALPITATIONS
|
4.0%
3/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.5%
2/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/75 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/79 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.9%
1/17 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Additional Information
Jeff Chodakewitz, M.D.
Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60