Trial Outcomes & Findings for A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV) (NCT NCT00627926)
NCT ID: NCT00627926
Last Updated: 2014-08-08
Results Overview
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1095 participants
Primary outcome timeframe
24 weeks after last planned dose of study treatment (up to Week 72)
Results posted on
2014-08-08
Participant Flow
A total of 1095 subjects were enrolled, of which 7 subjects discontinued the study prior to study drug administration. A total of 1088 subjects started treatment.
Participant milestones
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
361
|
364
|
363
|
|
Overall Study
COMPLETED
|
202
|
260
|
268
|
|
Overall Study
NOT COMPLETED
|
159
|
104
|
95
|
Reasons for withdrawal
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
26
|
37
|
36
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
118
|
40
|
38
|
|
Overall Study
Noncompliance/unspecified
|
8
|
23
|
17
|
Baseline Characteristics
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Baseline characteristics by cohort
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Total
n=1088 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
357 Participants
n=5 Participants
|
359 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
1069 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
452 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
636 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
214 participants
n=5 Participants
|
227 participants
n=7 Participants
|
214 participants
n=5 Participants
|
655 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
106 participants
n=5 Participants
|
100 participants
n=7 Participants
|
104 participants
n=5 Participants
|
310 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
24 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after last planned dose of study treatment (up to Week 72)Population: The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
SVR: Protocol Defined
|
158 participants
|
250 participants
|
271 participants
|
|
Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
SVR: FDA Guidance
|
166 participants
|
261 participants
|
285 participants
|
SECONDARY outcome
Timeframe: Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Undetectable HCV RNA at Week 72
|
158 participants
|
243 participants
|
265 participants
|
SECONDARY outcome
Timeframe: Week 4Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
|
34 participants
|
242 participants
|
246 participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
|
29 participants
|
207 participants
|
212 participants
|
SECONDARY outcome
Timeframe: Week 12Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Undetectable HCV RNA at Week 12
|
146 participants
|
277 participants
|
283 participants
|
SECONDARY outcome
Timeframe: End of treatment (up to Week 48)Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
|
229 participants
|
295 participants
|
314 participants
|
SECONDARY outcome
Timeframe: 12 weeks after last planned dose of study treatment (up to Week 60)Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
|
161 participants
|
255 participants
|
275 participants
|
SECONDARY outcome
Timeframe: 24 weeks after last actual dose of study treatment (up to Week 72)Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
|
158 participants
|
251 participants
|
274 participants
|
SECONDARY outcome
Timeframe: After last dose of study drug up to 24 week 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 quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=229 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=295 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=314 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
Viral Relapse Planned
|
64 participants
|
28 participants
|
27 participants
|
|
Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
Viral Relapse Actual
|
64 participants
|
28 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.
Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (\<1.25\*upper limit of normal \[ULN\]); Grade 1 (mild=1.25 to 2.5\*ULN); Grade 2 (moderate=2.6 to 5.0\*ULN); Grade 3 (severe= greater than 5.0 to 20.0\*ULN); Grade 4 (life-threatening= greater than 20.0\*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
ALT Grade 4 toxicity grade shift
|
0 participants
|
1 participants
|
0 participants
|
|
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
AST Grade 4 toxicity grade shift
|
1 participants
|
0 participants
|
0 participants
|
|
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
ALT Grade 3 toxicity grade shift
|
12 participants
|
5 participants
|
6 participants
|
|
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
AST Grade 3 toxicity grade shift
|
19 participants
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)Population: The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "number of participants analyzed" signifies those subjects who were evaluable for FibroTest Analysis and "n" signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively.
FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=273 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=233 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=261 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
SVR achieved (136, 180, 214)
|
35 participants
|
59 participants
|
84 participants
|
|
Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
SVR not achieved (137, 53, 47)
|
31 participants
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, 36, 48, 72Population: The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "n" signifies those participants who were evaluable for this measure at given time points for each group, respectively.
FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.
Outcome measures
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Fatigue Severity Scale (FSS) Total Score
Week 48 (n=286, 282, 294)
|
4.0 units on a scale
Standard Deviation 1.82
|
3.0 units on a scale
Standard Deviation 1.75
|
3.1 units on a scale
Standard Deviation 1.85
|
|
Fatigue Severity Scale (FSS) Total Score
Week 72 (n=296, 270, 289)
|
2.9 units on a scale
Standard Deviation 1.77
|
2.6 units on a scale
Standard Deviation 1.56
|
2.6 units on a scale
Standard Deviation 1.67
|
|
Fatigue Severity Scale (FSS) Total Score
Baseline (n=343, 351, 346)
|
3.0 units on a scale
Standard Deviation 1.66
|
3.2 units on a scale
Standard Deviation 1.63
|
3.0 units on a scale
Standard Deviation 1.72
|
|
Fatigue Severity Scale (FSS) Total Score
Week 4 (n=334, 326, 329)
|
4.1 units on a scale
Standard Deviation 1.74
|
4.4 units on a scale
Standard Deviation 1.74
|
4.5 units on a scale
Standard Deviation 1.75
|
|
Fatigue Severity Scale (FSS) Total Score
Week 24 (n=317, 307, 304)
|
4.3 units on a scale
Standard Deviation 1.73
|
4.3 units on a scale
Standard Deviation 1.71
|
4.3 units on a scale
Standard Deviation 1.79
|
|
Fatigue Severity Scale (FSS) Total Score
Week 36 (n=296, 282, 297)
|
4.1 units on a scale
Standard Deviation 1.80
|
3.4 units on a scale
Standard Deviation 1.84
|
3.3 units on a scale
Standard Deviation 1.86
|
|
Fatigue Severity Scale (FSS) Total Score
Week 12 (n=329, 310, 312)
|
4.4 units on a scale
Standard Deviation 1.69
|
4.4 units on a scale
Standard Deviation 1.68
|
4.8 units on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: The FA set included all randomized subjects who received at least 1 dose of any 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=361 Participants
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 Participants
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 Participants
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
354 participants
|
362 participants
|
361 participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
24 participants
|
31 participants
|
33 participants
|
Adverse Events
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Serious events: 24 serious events
Other events: 354 other events
Deaths: 0 deaths
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Serious events: 31 serious events
Other events: 362 other events
Deaths: 0 deaths
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Serious events: 33 serious events
Other events: 361 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
n=361 participants at risk
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 participants at risk
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 participants at risk
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
pneumonia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.55%
2/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
appendicitis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
pyelonephritis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
urinary tract infection
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.55%
2/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
abscess
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
chest pain
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
abscess limb
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
acute sinusitis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
bacteraemia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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 staphylococcal
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
escherichia bacteraemia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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 viral
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
lung abscess
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
lymphangitis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
perirectal abscess
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
respiratory tract infection
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
staphylococcal abscess
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
staphylococcal infection
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
subcutaneous abscess
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
tuberculosis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
anemia
|
1.1%
4/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
10/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.2%
8/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
anemia haemolytic
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
leukopenia
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
thrombocytopenia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.82%
3/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.55%
2/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
leukocytoclastic vasculitis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
stevens-johnson syndrome
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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 fistula
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
diverticular perforation
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
inguinal hernia
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
internal hernia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
intestinal ischaemia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
pancreatitis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
pancreatitis acute
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
salivary gland calculus
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
syncope
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.83%
3/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
convulsion
|
0.55%
2/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
migraine
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
altered state of consciousness
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
global amnesia
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
completed suicide
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
panic attack
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
psychotic disorder
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
costochondritis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
intervertebral disc
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
rheumatoid arthritis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
atrial fibrillation
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
angina pectoris
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
renal failure acute
|
0.55%
2/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
nephrolithiasis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
urinary retention
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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 haemorrhage
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
cholecystitis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
cholelithiasis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
hepatic cirrhosis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
hepatitis acute
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
hypotension
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
phlebitis
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
thrombophlebitis
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
hyponatraemia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.27%
1/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Congenital, familial and genetic disorders
urachal abnormality
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Immune system disorders
cryoglobulinaemia
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
thermal burn
|
0.28%
1/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Reproductive system and breast disorders
metrorrhagia
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
0.00%
0/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
0/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.28%
1/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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=361 participants at risk
Placebo (PBO) matched to telaprevir 750 mg tablet 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 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=364 participants at risk
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 to 48 weeks depending on individual response to telaprevir treatment.
|
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
n=363 participants at risk
Telaprevir 750 mg 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 to 48 weeks depending on individual response to telaprevir treatment.
|
|---|---|---|---|
|
General disorders
fatigue
|
57.1%
206/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
58.0%
211/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
57.0%
207/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
28.0%
101/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
28.8%
105/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
28.1%
102/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
24.1%
87/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
29.7%
108/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.2%
95/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
17.7%
64/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.7%
68/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
22.0%
80/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
asthenia
|
16.1%
58/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.0%
62/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.4%
56/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
15.0%
54/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.9%
65/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
46/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
9.1%
33/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.6%
46/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
38/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
7.8%
28/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.2%
30/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.0%
18/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
36.3%
131/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
45.3%
165/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
49.9%
181/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
24.4%
88/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
35.4%
129/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.6%
133/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
20.2%
73/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
22.3%
81/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
22.9%
83/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
18.3%
66/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.1%
66/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.4%
63/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
4.2%
15/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.5%
20/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.6%
24/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.6%
13/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.0%
22/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.1%
22/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
4.4%
16/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
13/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.7%
17/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.0%
11/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.7%
17/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.4%
16/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.9%
14/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.9%
18/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.8%
10/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
1.9%
7/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.7%
10/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
23/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
31.0%
112/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
40.1%
146/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
156/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
22.2%
80/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
115/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
28.1%
102/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
10.5%
38/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.1%
55/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
55/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.6%
13/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
43/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
43/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
anorectal discomfort
|
3.6%
13/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.2%
30/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
46/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
8.3%
30/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.9%
36/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.9%
36/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
9.4%
34/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.7%
28/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.5%
20/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
6.4%
23/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.1%
15/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.1%
33/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.3%
12/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
26/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.4%
27/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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 pruritus
|
1.9%
7/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.9%
25/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.5%
31/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
39.3%
142/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
42.9%
156/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
40.8%
148/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
13.6%
49/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.7%
50/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.7%
57/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
distrubance in attention
|
9.1%
33/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.0%
29/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.9%
25/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.9%
14/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.9%
36/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.4%
34/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
30.7%
111/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
31.9%
116/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
32.2%
117/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
21.9%
79/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.8%
61/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
18.2%
66/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
12.2%
44/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.1%
33/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.6%
35/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
affect lability
|
3.3%
12/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
1.4%
5/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.7%
17/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
19.4%
70/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
38.7%
141/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
37.2%
135/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
18.8%
68/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
17.0%
62/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.0%
51/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
23.8%
86/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.9%
76/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.8%
61/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
13.9%
50/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.3%
52/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
12.9%
47/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
6.4%
23/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.4%
27/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.2%
26/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
5.3%
19/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.9%
25/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.7%
28/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
21.3%
77/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
20.9%
76/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.9%
54/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
18.8%
68/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.4%
56/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
13.5%
49/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
11.9%
43/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.9%
25/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.7%
28/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
3.6%
13/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
2.2%
8/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.2%
19/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
urinary tract infection
|
3.6%
13/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.0%
22/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
4.7%
17/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
5.0%
18/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.2%
19/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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%
9/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
10.8%
39/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.1%
55/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
14.6%
53/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
7.5%
27/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
7.1%
26/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.0%
29/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
6.1%
22/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
3.6%
13/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
6.6%
24/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
4.2%
15/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.8%
32/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
9.1%
33/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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
|
7.5%
27/361 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.5%
20/364 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
8.5%
31/363 • AEs and SAEs During Dosing From Baseline to Week 48
In the event a single participant has experienced both a serious and a non-serious 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