Trial Outcomes & Findings for To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (NCT NCT04426890)
NCT ID: NCT04426890
Last Updated: 2025-07-29
Results Overview
The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
634 participants
Primary outcome timeframe
Week 12
Results posted on
2025-07-29
Participant Flow
A total of 783 patients were screened for the study. Of these, 149 patients were excluded from the study due to screening failure and 634 patients were enrolled in the study. Of these 634 patients, 15 patients from the significantly GCP noncompliant study center were excluded from all analysis population. Finally, total of 619 patients were included in the data analysis.
Participant milestones
| Measure |
Arm 1
Received CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintained CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
Received Xolair 300 mg every 4 weeks in TP1 and re-randomized at Week 12 to Arm 2-1 or Arm 2-2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-1
Received Xolair 300 mg every 4 weeks in TP1 and re-randomized to switch to CT-P39 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-2
Received Xolair 300 mg every 4 weeks in TP1 and maintained Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
Received CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increased to CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (Week 0 to Week 12)
STARTED
|
204
|
205
|
0
|
0
|
107
|
103
|
|
Treatment Period 1 (Week 0 to Week 12)
COMPLETED
|
187
|
192
|
0
|
0
|
101
|
98
|
|
Treatment Period 1 (Week 0 to Week 12)
NOT COMPLETED
|
17
|
13
|
0
|
0
|
6
|
5
|
|
Treatment Period 2 (Week 12 to Week 24)
STARTED
|
187
|
0
|
96
|
96
|
101
|
98
|
|
Treatment Period 2 (Week 12 to Week 24)
COMPLETED
|
181
|
0
|
94
|
94
|
99
|
94
|
|
Treatment Period 2 (Week 12 to Week 24)
NOT COMPLETED
|
6
|
0
|
2
|
2
|
2
|
4
|
|
Follow Up Period
STARTED
|
182
|
184
|
0
|
0
|
98
|
90
|
|
Follow Up Period
COMPLETED
|
172
|
172
|
0
|
0
|
91
|
83
|
|
Follow Up Period
NOT COMPLETED
|
10
|
12
|
0
|
0
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Baseline characteristics by cohort
| Measure |
Arm 1
n=204 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150 mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Total
n=619 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
42.8 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
403 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
500 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Region of Enrollment
Greece
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
262 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Baseline ISS7
< 13 points
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Baseline ISS7
≥ 13 points
|
168 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
504 Participants
n=21 Participants
|
|
Weight on Day 1,
< 80 kg
|
123 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
378 Participants
n=21 Participants
|
|
Weight on Day 1,
≥ 80 kg
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups
|
-9.25 score on a scale
Standard Error 0.787
|
-9.96 score on a scale
Standard Error 0.791
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency was not calculated due to the assumption of parallel-line assay not being met. A parallel-line assay assumes that dose-efficacy response relationships are linear and parallel on log-dose scale which requires the equal slope in the regression model used to estimate relative potency. However, the slopes of the two treatment groups were estimated to be different, indicating a violation of the parallelism assumption. As a result, the relative potency was not computed.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12
|
NA participants
The relative potency was not calculated due to assumption of parallel-line assay not being met.
|
NA participants
The relative potency was not calculated due to assumption of parallel-line assay not being met.
|
NA participants
The relative potency was not calculated due to assumption of parallel-line assay not being met.
|
NA participants
The relative potency was not calculated due to assumption of parallel-line assay not being met.
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in ISS7 at Week 12 was calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency based on the CFB of ISS7 at Week 12 was not calculated due to assumption of parallel-line assay not being met.
Outcome measures
| Measure |
Arm 1
n=186 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=192 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=101 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=94 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12
|
-9.31 score on a scale
Standard Deviation 6.20
|
-9.99 score on a scale
Standard Deviation 6.18
|
-9.56 score on a scale
Standard Deviation 5.87
|
-8.73 score on a scale
Standard Deviation 6.65
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in ISS7 at Week 24 was calculated as ISS7 at Week 24 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Arm 1
n=170 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=88 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=82 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=90 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=86 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24
|
-11.22 score on a scale
Standard Deviation 6.21
|
-12.24 score on a scale
Standard Deviation 5.69
|
-11.19 score on a scale
Standard Deviation 5.88
|
-11.76 score on a scale
Standard Deviation 5.61
|
-10.70 score on a scale
Standard Deviation 6.17
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
Time to MID response was the time (in weeks) from Day 1 to the study week when reduction of 5 points or more from baseline for ISS7 was first achieved up to Week 12. If a patient failed to achieve an MID response up to Week 12 or terminated the study prior to Week 12 without achieving MID response, the patient was censored at the date (in weeks) of the last non-missing ISS7 evaluation. Time to MID was estimated by Kaplan-Meier method. The lower result means a better outcome.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Time to Minimally Important Difference (MID) in ISS7 by Week 12
|
2.00 in Weeks
Interval 2.0 to 3.0
|
2.00 in Weeks
Interval 2.0 to 3.0
|
2.00 in Weeks
Interval 2.0 to 3.0
|
2.00 in Weeks
Interval 2.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
Number of patients who achieved MID response at Week 12 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. The higher percentage means a better outcome.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12
|
141 Participants
|
152 Participants
|
78 Participants
|
65 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in HSS7 at Week 12 was calculated as HSS7 at Week 12 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Arm 1
n=186 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=192 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=101 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=94 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
|
-9.96 score on a scale
Standard Deviation 6.88
|
-10.55 score on a scale
Standard Deviation 6.93
|
-10.29 score on a scale
Standard Deviation 6.75
|
-9.48 score on a scale
Standard Deviation 6.93
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in HSS7 at Week 24 was calculated as HSS7 at Week 24 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Arm 1
n=170 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=88 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=82 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=90 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=86 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24
|
-11.86 score on a scale
Standard Deviation 6.72
|
-12.72 score on a scale
Standard Deviation 6.72
|
-12.36 score on a scale
Standard Deviation 6.64
|
-12.74 score on a scale
Standard Deviation 6.01
|
-11.77 score on a scale
Standard Deviation 6.20
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in UAS7 at Week 12 was calculated as UAS7 at Week 12 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Arm 1
n=186 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=192 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=101 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=94 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
|
-19.27 score on a scale
Standard Deviation 12.53
|
-20.54 score on a scale
Standard Deviation 12.69
|
-19.84 score on a scale
Standard Deviation 12.02
|
-18.21 score on a scale
Standard Deviation 13.06
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in UAS7 at Week 24 was calculated as UAS7 at Week 24 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Arm 1
n=170 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=88 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=82 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=90 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=86 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24
|
-23.08 score on a scale
Standard Deviation 12.30
|
-24.96 score on a scale
Standard Deviation 11.79
|
-23.55 score on a scale
Standard Deviation 12.08
|
-24.50 score on a scale
Standard Deviation 11.13
|
-22.48 score on a scale
Standard Deviation 11.84
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
Percentage of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 12 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12
Patients with UAS7 ≤ 6
|
77 Participants
|
83 Participants
|
41 Participants
|
33 Participants
|
—
|
|
Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12
Patients with UAS7 = 0
|
48 Participants
|
63 Participants
|
23 Participants
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The number of patients with Weekly Urticaria Activity Score (UAS7) of ≤ 6 points and complete responders (UAS7 = 0) at Week 24 is presented. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. UAS7 can range from 0 to 42. The higher result means a better outcome.
Outcome measures
| Measure |
Arm 1
n=187 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=96 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=96 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=101 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=98 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24
Patients with UAS7 of ≤ 6
|
102 Participants
|
65 Participants
|
46 Participants
|
55 Participants
|
41 Participants
|
|
Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24
Patients with UAS7 = 0
|
75 Participants
|
49 Participants
|
36 Participants
|
39 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Week 4 to 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The proportion of angioedema-free days from Week 4 to Week 12 is defined as the number of days for which the patient indicated a 'No' response to the angioedema question in the patient eDiary divided by the total number of days with a non-missing diary entry starting on Week 4 visit date and ending the day prior to Week 12 visit date. Patients who had missing responses for \> 40% of the daily diary entries between Week 4 visit date and Week 12 visit date were not included in this analysis. The higher result means a better outcome.
Outcome measures
| Measure |
Arm 1
n=189 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=190 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=99 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=97 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Percentage of Angioedema-Free Days From Week 4 to Week 12
|
93.47 percentage of Angioedema-Free Days
Standard Deviation 17.95
|
90.14 percentage of Angioedema-Free Days
Standard Deviation 25.64
|
96.94 percentage of Angioedema-Free Days
Standard Deviation 10.83
|
93.77 percentage of Angioedema-Free Days
Standard Deviation 18.01
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in the number of tablets/week of rescue therapy used at Week 12 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary.
Outcome measures
| Measure |
Arm 1
n=170 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=180 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=92 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=85 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 12
|
-1.33 Number of Tablets/Week
Standard Deviation 3.73
|
-1.45 Number of Tablets/Week
Standard Deviation 3.16
|
-1.19 Number of Tablets/Week
Standard Deviation 2.71
|
-1.53 Number of Tablets/Week
Standard Deviation 3.42
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in the number of tablets/week of rescue therapy used at Week 24 is presented. The number of tablets for each week of rescue therapy will be defined as the sum of daily use of rescue therapy over the study days which make up a given study week. The higher value means a worse outcome. If a subject switched rescue therapy medication and started a different medication or the prescribed dose of the rescue therapy medication changed during the study, the subject was excluded from the summary.
Outcome measures
| Measure |
Arm 1
n=154 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=78 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=79 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=81 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=78 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 24
|
-1.40 Number of Tablets/Week
Standard Deviation 3.79
|
-1.75 Number of Tablets/Week
Standard Deviation 3.67
|
-1.74 Number of Tablets/Week
Standard Deviation 2.98
|
-1.50 Number of Tablets/Week
Standard Deviation 3.36
|
-1.77 Number of Tablets/Week
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in mean overall DLQI score at Week 12 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome.
Outcome measures
| Measure |
Arm 1
n=169 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=179 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=98 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=91 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
|
-8.9 score on a scale
Standard Deviation 7.5
|
-9.0 score on a scale
Standard Deviation 6.7
|
-9.2 score on a scale
Standard Deviation 7.0
|
-8.9 score on a scale
Standard Deviation 8.2
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in mean overall DLQI score at Week 24 is presented. The DLQI is a 10-item dermatology-specific health-related questionnaire across 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspect of their lives. Each question is scored from 0 to 3. Overall DLQI ranges on a scale of 0 to 30. The higher result means a worse outcome.
Outcome measures
| Measure |
Arm 1
n=161 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=87 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=87 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=93 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=89 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24
|
-9.4 score on a scale
Standard Deviation 6.9
|
-10.4 score on a scale
Standard Deviation 7.3
|
-9.8 score on a scale
Standard Deviation 6.9
|
-10.5 score on a scale
Standard Deviation 7.7
|
-10.1 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on mITT Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I.
The change from baseline in mean overall CU-Q2oL score at Week 12 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula:\[(sum of items - minimum) / (maximum - minimum)\] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items).
Outcome measures
| Measure |
Arm 1
n=178 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=186 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=100 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=94 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12
|
-25.40 score on a scale
Standard Deviation 20.33
|
-28.11 score on a scale
Standard Deviation 19.93
|
-27.32 score on a scale
Standard Deviation 20.81
|
-26.51 score on a scale
Standard Deviation 23.27
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II.
The change from baseline in mean overall CU-Q2oL score at Week 24 is presented. The CU-Q2oL is a 23-item CSU specific health-related QoL questionnaire across 6 domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Patients rated their CSU symptoms and the impact of their CSU on various aspects of their lives. Each question was scored from 1 (not at all) to 5 (extremely), and overall raw score, on a scale of 23 to 115, was calculated by summing the individual raw domain scores. The higher result means a worse outcome. Overall raw scores of CU-Q2oL were converted to 0 to 100 point scores according to the following formula: \[(sum of items - minimum) / (maximum - minimum)\] × 100, where minimum=23 (1 score for all 23 items), maximum=115 (5 score for all 23 items)
Outcome measures
| Measure |
Arm 1
n=167 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=90 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=89 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=94 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=90 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24
|
-29.19 score on a scale
Standard Deviation 18.76
|
-31.33 score on a scale
Standard Deviation 21.95
|
-31.88 score on a scale
Standard Deviation 22.33
|
-31.71 score on a scale
Standard Deviation 19.96
|
-30.88 score on a scale
Standard Deviation 22.22
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on PK Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The PK Set was defined as all patients who received at least 1 full dose of either of the study drugs during Treatment Period I and had at least 1 post-treatment PK result prior to dosing at Week 12.
All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0).
Outcome measures
| Measure |
Arm 1
n=187 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=193 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=101 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=97 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Omalizumab at Week 12
|
31.50791 ug/mL
Standard Deviation 12.11966
|
31.35679 ug/mL
Standard Deviation 13.44334
|
14.67465 ug/mL
Standard Deviation 6.31588
|
15.80010 ug/mL
Standard Deviation 7.65671
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on PK-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The PK-TP2 Subset was defined as all patients in PK Set who received at least 1 full dose of either of the study drugs during Treatment Period II and had at least 1 post-treatment PK result after Week 12
All concentration below lower limit of quantification (BLQ) values were treated as zero (0) for PK parameter summary. Below lower limit of quantification (BLQ) is treated as zero (0).
Outcome measures
| Measure |
Arm 1
n=177 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=92 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=94 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=97 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=92 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Omalizumab at Week 24
|
35.43099 ug/mL
Standard Deviation 14.98897
|
35.87102 ug/mL
Standard Deviation 18.09287
|
33.50606 ug/mL
Standard Deviation 14.25536
|
30.41523 ug/mL
Standard Deviation 13.16691
|
33.63630 ug/mL
Standard Deviation 16.55088
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed based on Safety Set which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs.
Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment.
Outcome measures
| Measure |
Arm 1
n=203 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=205 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=107 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=103 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Immunogenicity Result at Week 12
ADA positive
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Immunogenicity Result at Week 12
NAb positive (in ADA positive patients)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed based on Safety-TP2 Subset which had different definition with RAN set for disposition table. This table presents the actual number of patients who had a result and were included in the analysis. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
Anti-drug Antibody test involved both screening and confirmatory assays to confirm true positive results. Samples that are positive in the screening assay underwent further testing in the confirmatory assay to determine if patients are true positive. Samples that are positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment.
Outcome measures
| Measure |
Arm 1
n=187 Participants
Received 300 mg of CT-P39 as SC injections via PFS during Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2
n=96 Participants
Received 300 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3
n=96 Participants
Received 150mg of CT-P39 as SC injections via PFS during TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=101 Participants
Received 150 mg of EU-approved Xolair as SC injections via PFS during TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4
n=98 Participants
Received Xolair 150 mg in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|
|
Immunogenicity Result at Week 24
ADA positive
|
9 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Immunogenicity Result at Week 24
NAb positive (in ADA positive patients)
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Arm 1/Treatment Period 1
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Arm 2/ Treatment Period 1
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 3/ Treatment Period 1
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 4/ Treatment Period 1
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 1/Treatment Period 2
Serious events: 5 serious events
Other events: 16 other events
Deaths: 1 deaths
Arm 2-1/ Treatment Period 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2-2/Treatment Period 2
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 3/ Treatment Period 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 4/ Treatment Period 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 1/Follow-up Period
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2/Follow-up Period
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm 3/Follow-up Period
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 4/Follow-up Period
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1/Treatment Period 1
n=203 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2/ Treatment Period 1
n=205 participants at risk
Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/ Treatment Period 1
n=107 participants at risk
Received 150mg of CT-P39 as SC injections via PFS in TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/ Treatment Period 1
n=103 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 1/Treatment Period 2
n=187 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1) and maintained CT-P39 300 mg in Treatment Period 2 (TP2)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-1/ Treatment Period 2
n=96 participants at risk
Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and switched to CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-2/Treatment Period 2
n=96 participants at risk
Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and maintained Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/ Treatment Period 2
n=101 participants at risk
Received 150 mg of CT-P39 as SC injections via PFS in TP1 and increased to CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/ Treatment Period 2
n=98 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 1/Follow-up Period
n=203 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2/Follow-up Period
n=205 participants at risk
Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/Follow-up Period
n=107 participants at risk
Received 150mg of CT-P39 as SC injections via PFS in TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/Follow-up Period
n=103 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Gastrointestinal disorders
Colitis
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
General disorders
Oedema peripheral
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
COVID-19
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Infection
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Investigations
Tryptase increased
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Vascular disorders
Behcet's syndrome
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
Other adverse events
| Measure |
Arm 1/Treatment Period 1
n=203 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2/ Treatment Period 1
n=205 participants at risk
Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/ Treatment Period 1
n=107 participants at risk
Received 150mg of CT-P39 as SC injections via PFS in TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/ Treatment Period 1
n=103 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 1/Treatment Period 2
n=187 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1) and maintained CT-P39 300 mg in Treatment Period 2 (TP2)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-1/ Treatment Period 2
n=96 participants at risk
Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and switched to CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2-2/Treatment Period 2
n=96 participants at risk
Received 300 mg of EU-approved Xolair as SC injection via PFS in TP1 and maintained Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/ Treatment Period 2
n=101 participants at risk
Received 150 mg of CT-P39 as SC injections via PFS in TP1 and increased to CT-P39 300 mg in TP2
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/ Treatment Period 2
n=98 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1 and increased to Xolair 300 mg in TP2
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 1/Follow-up Period
n=203 participants at risk
Received 300 mg of CT-P39 as SC injections via PFS in Treatment Period 1 (TP1)
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 2/Follow-up Period
n=205 participants at risk
Received 300 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
Arm 3/Follow-up Period
n=107 participants at risk
Received 150mg of CT-P39 as SC injections via PFS in TP1
CT-P39: Prefilled syringe (PFS) of 1 mL solution
|
Arm 4/Follow-up Period
n=103 participants at risk
Received 150 mg of EU-approved Xolair as SC injections via PFS in TP1
EU-approved Xolair: Prefilled syringe (PFS) of 1 mL solution
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.5%
5/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.4%
7/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.7%
4/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.7%
5/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.1%
2/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.0%
2/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.1%
3/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.99%
2/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.9%
8/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.7%
4/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
4.9%
5/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.8%
3/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.9%
2/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Nervous system disorders
Headache
|
2.5%
5/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.4%
5/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.9%
4/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.1%
2/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.99%
2/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.8%
3/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.1%
2/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
General disorders
Injection site reaction
|
2.5%
5/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
4.4%
9/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.9%
3/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.53%
1/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.1%
3/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.1%
2/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.99%
1/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
7/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.0%
4/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
6.5%
7/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.9%
2/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.2%
6/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
2.1%
2/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
4.2%
4/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.99%
1/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.5%
3/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
3.4%
7/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.5%
3/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.93%
1/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.97%
1/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.6%
3/187 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/96 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
4.0%
4/101 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
1.0%
1/98 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.49%
1/203 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.98%
2/205 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/107 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
0.00%
0/103 • Treatment-Emergent Adverse Event Up to Week 40. The 'Other Adverse Events' table includes only non-serious treatment-emergent AEs that occurred in ≥2% of patients in at least one arm/period group. Each patient is counted only once, even if they reported multiple AEs for the total patient number of each arm/period group.
The data includes treatment-emergent adverse event during overall period. For treatment Period 2, the summary is presented in the Safety TP2 Subset, and Others are presented in the Safety Set. The Safety Set was defined as all randomly assigned patients who received at least 1 dose (full or partial) of either of the study drugs. The Safety-TP2 Subset was defined as all patients in Safety Set who received at least 1 dose (full or partial) of either of the study drugs during Treatment Period II.
|
Additional Information
Yunju Bae/Head of Clinical Planning 1 Department
Celltrion. Inc
Phone: +82 32 850 4160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place