Trial Outcomes & Findings for A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD (NCT NCT04535986)
NCT ID: NCT04535986
Last Updated: 2023-11-13
Results Overview
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
763 participants
Primary outcome timeframe
Baseline (pre-dose on Day 1) and Week 12
Results posted on
2023-11-13
Participant Flow
This Phase 3, randomized, double-blind, placebo-controlled study was conducted in patients with moderate to severe chronic obstructive pulmonary disease (COPD) at 120 study centers in 12 countries between 29 Sep 2020 and 02 Dec 2022. Patients were randomized in a 5:3 ratio overall (1:1 over 24 weeks and 3:1 over 48 weeks), stratified by duration, smoking status and background medication use, to receive either ensifentrine or placebo.
Patients were screened for eligibility before entering a 28-day run in period to ensure a stable COPD treatment regimen and to collect baseline information on symptoms and rescue medication use.
Participant milestones
| Measure |
Ensifentrine
3 milligram (mg) twice daily via standard jet nebulizer.
|
Placebo
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
Overall Study
STARTED
|
479
|
284
|
|
Overall Study
Received Treatment
|
477
|
283
|
|
Overall Study
COMPLETED
|
400
|
245
|
|
Overall Study
NOT COMPLETED
|
79
|
39
|
Reasons for withdrawal
| Measure |
Ensifentrine
3 milligram (mg) twice daily via standard jet nebulizer.
|
Placebo
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
Overall Study
Death
|
4
|
5
|
|
Overall Study
COPD exacerbation withdrawal criteria
|
7
|
5
|
|
Overall Study
Coronavirus disease 2019 (COVID-19)
|
8
|
6
|
|
Overall Study
Adverse Event
|
10
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
|
Overall Study
Investigator discretion
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
32
|
14
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Other
|
7
|
3
|
Baseline Characteristics
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
Baseline characteristics by cohort
| Measure |
Ensifentrine
n=479 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=284 Participants
Twice daily via standard jet nebulizer.
|
Total
n=763 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 7.73 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 7.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
437 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
688 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
464 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
28 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
70 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
117 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
71 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Week 12Population: The modified Intent-to-Treat (mITT) population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment. 1 patient was missing a baseline FEV1 assessment.
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Outcome measures
| Measure |
Ensifentrine
n=477 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=282 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
Least Square (LS) Mean Change From Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12
|
0.0611 liters
Standard Error 0.01825
|
-0.0256 liters
Standard Error 0.0195
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1), post-dose on Day 1, Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines.
Outcome measures
| Measure |
Ensifentrine
n=477 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=282 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24
Week 12
|
0.2042 liters
Standard Error 0.0201
|
0.0570 liters
Standard Error 0.0217
|
|
LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24
Week 24
|
0.1623 liters
Standard Error 0.0217
|
0.0462 liters
Standard Error 0.0234
|
|
LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24
Day 1 (Post-dose)
|
0.2274 liters
Standard Error 0.0130
|
0.0755 liters
Standard Error 0.0138
|
|
LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24
Week 6
|
0.2038 liters
Standard Error 0.0193
|
0.0677 liters
Standard Error 0.0207
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
The E-RS scale consists of 11 questions, with 3 sub-domains of: breathlessness, cough and sputum, and chest symptoms. The E-RS sub-domain score was calculated as the sum from the relevant questions. The E-RS total score was derived as the sum of the raw scores of the 11 items ranging from 0 to 40. Higher scores indicates severe respiratory symptoms. Scores were derived weekly as the mean over 7 days prior to the visit, using only days where data was recorded. The E-RS was collected daily by electronic diary (e-diary). Baseline is the mean over the 7 days prior to the first intake of study medication, using only days where data was recorded.
Outcome measures
| Measure |
Ensifentrine
n=475 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=281 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline to the Mean Weekly Evaluating-Respiratory Symptoms (E-RS) Total Score at Weeks 6, 12 and 24
Week 6
|
-1.944 units on a scale
Standard Error 0.3581
|
-1.157 units on a scale
Standard Error 0.3831
|
|
LS Mean Change From Baseline to the Mean Weekly Evaluating-Respiratory Symptoms (E-RS) Total Score at Weeks 6, 12 and 24
Week 12
|
-2.498 units on a scale
Standard Error 0.3897
|
-1.127 units on a scale
Standard Error 0.4176
|
|
LS Mean Change From Baseline to the Mean Weekly Evaluating-Respiratory Symptoms (E-RS) Total Score at Weeks 6, 12 and 24
Week 24
|
-2.249 units on a scale
Standard Error 0.4247
|
-1.298 units on a scale
Standard Error 0.4573
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Score ranging from 0 to 100 and higher scores indicated a worse outcome. Baseline is the score calculated on Day 1 prior to 4 hour post-dose spirometry.
Outcome measures
| Measure |
Ensifentrine
n=474 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=281 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 6, 12 and 24
Week 6
|
-6.184 units on a scale
Standard Error 0.9838
|
-3.965 units on a scale
Standard Error 1.0511
|
|
LS Mean Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 6, 12 and 24
Week 12
|
-5.665 units on a scale
Standard Error 1.0163
|
-2.652 units on a scale
Standard Error 1.0859
|
|
LS Mean Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 6, 12 and 24
Week 24
|
-6.167 units on a scale
Standard Error 1.1405
|
-3.868 units on a scale
Standard Error 1.2178
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Morning trough FEV1 was the last value collected prior to the morning dose. Baseline FEV1 is the mean of the two measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines.
Outcome measures
| Measure |
Ensifentrine
n=477 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=282 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline FEV1 to Morning Trough FEV1 at Weeks 6, 12 and 24
Week 12
|
0.0076 liters
Standard Error 0.0190
|
-0.0272 liters
Standard Error 0.0204
|
|
LS Mean Change From Baseline FEV1 to Morning Trough FEV1 at Weeks 6, 12 and 24
Week 6
|
0.0112 liters
Standard Error 0.0181
|
-0.0259 liters
Standard Error 0.0193
|
|
LS Mean Change From Baseline FEV1 to Morning Trough FEV1 at Weeks 6, 12 and 24
Week 24
|
-0.0236 liters
Standard Error 0.0205
|
-0.0369 liters
Standard Error 0.0219
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1), post-dose on Day 1, Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-4h was defined as area under the curve over 4 hours of the FEV1, divided by 4 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines.
Outcome measures
| Measure |
Ensifentrine
n=477 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=282 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline in Average FEV1 Area Under the Curve Over 4 Hours (AUC0-4h) at Day 1 and Weeks 6, 12 and 24
Week 24
|
0.0875 liters
Standard Error 0.0206
|
-0.0139 liters
Standard Error 0.0220
|
|
LS Mean Change From Baseline in Average FEV1 Area Under the Curve Over 4 Hours (AUC0-4h) at Day 1 and Weeks 6, 12 and 24
Day 1 (Post-dose)
|
0.1495 liters
Standard Error 0.0108
|
0.0099 liters
Standard Error 0.0115
|
|
LS Mean Change From Baseline in Average FEV1 Area Under the Curve Over 4 Hours (AUC0-4h) at Day 1 and Weeks 6, 12 and 24
Week 6
|
0.1259 liters
Standard Error 0.0184
|
-0.0044 liters
Standard Error 0.0196
|
|
LS Mean Change From Baseline in Average FEV1 Area Under the Curve Over 4 Hours (AUC0-4h) at Day 1 and Weeks 6, 12 and 24
Week 12
|
0.1243 liters
Standard Error 0.0191
|
-0.0149 liters
Standard Error 0.0203
|
SECONDARY outcome
Timeframe: Weeks 6, 12 and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Responder was a patient with an improvement from baseline in SGRQ total score of 4 or more. Percentage of SGRQ responders are reported.
Outcome measures
| Measure |
Ensifentrine
n=474 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=281 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
Percentage of SGRQ Responders at Weeks 6, 12 and 24
Week 12
|
52.5 percentage of patients
|
37.0 percentage of patients
|
|
Percentage of SGRQ Responders at Weeks 6, 12 and 24
Week 6
|
50.8 percentage of patients
|
40.6 percentage of patients
|
|
Percentage of SGRQ Responders at Weeks 6, 12 and 24
Week 24
|
58.2 percentage of patients
|
45.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Weeks 6, 12, and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
Use of rescue medication (albuterol/salbutamol) per week was calculated as the LS mean use daily over 7 days. Daily rescue medication use was collected in an e-diary throughout the study. Baseline is the mean over the 7 days prior to the first intake of study medication, calculated as the sum of puffs taken, divided by number of days data has been recorded.
Outcome measures
| Measure |
Ensifentrine
n=475 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=281 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline to the Mean Weekly Rescue Medication Use at Weeks 6, 12 and 24
Week 6
|
-0.442 rescue medication puffs per week
Standard Error 0.1065
|
-0.306 rescue medication puffs per week
Standard Error 0.1139
|
|
LS Mean Change From Baseline to the Mean Weekly Rescue Medication Use at Weeks 6, 12 and 24
Week 12
|
-0.469 rescue medication puffs per week
Standard Error 0.1155
|
-0.182 rescue medication puffs per week
Standard Error 0.1234
|
|
LS Mean Change From Baseline to the Mean Weekly Rescue Medication Use at Weeks 6, 12 and 24
Week 24
|
-0.506 rescue medication puffs per week
Standard Error 0.1448
|
-0.052 rescue medication puffs per week
Standard Error 0.1554
|
SECONDARY outcome
Timeframe: Weeks 6, 12 and 24Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
The TDI is a questionnaire that focused on 3 sub-domains: functional impairment, magnitude of task and magnitude of effort. Sub-domain score was calculated as the sum from the related questions. Total score was calculated as the sum of the sub-domain scores. The TDI measures the change in dyspnea severity from the baseline as measured by the baseline dyspnea index. It was rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement). Higher scores indicate better outcome. Change from baseline was assessed with the Baseline Dyspnea Index.
Outcome measures
| Measure |
Ensifentrine
n=471 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=277 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Transition Dyspnea Index (TDI) Questionnaire Total Score at Weeks 6, 12 and 24
Week 6
|
1.3 units on a scale
Standard Error 0.19
|
0.6 units on a scale
Standard Error 0.21
|
|
LS Mean Transition Dyspnea Index (TDI) Questionnaire Total Score at Weeks 6, 12 and 24
Week 12
|
1.6 units on a scale
Standard Error 0.21
|
0.4 units on a scale
Standard Error 0.23
|
|
LS Mean Transition Dyspnea Index (TDI) Questionnaire Total Score at Weeks 6, 12 and 24
Week 24
|
1.9 units on a scale
Standard Error 0.24
|
0.8 units on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 1) and Week 12Population: The mITT population set included all patients in the randomized set who received at least 1 dose (or partial dose) of study medication, and patients were classified according to randomized treatment.
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Evening trough FEV1 was the value collected at 12 hours post-morning dose and prior to the evening dose. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on day 1. Spirometry assessments were performed in accordance with ATS/ERS guidelines.
Outcome measures
| Measure |
Ensifentrine
n=477 Participants
3 mg twice daily via standard jet nebulizer.
|
Placebo
n=282 Participants
Twice daily via standard jet nebulizer.
|
|---|---|---|
|
LS Mean Change From Baseline FEV1 to Evening Trough FEV1 at Week 12
|
-0.0117 liters
Standard Error 0.0203
|
-0.0697 liters
Standard Error 0.0214
|
Adverse Events
Up to Week 24: Ensifentrine
Serious events: 32 serious events
Other events: 90 other events
Deaths: 2 deaths
Up to Week 24: Placebo
Serious events: 19 serious events
Other events: 58 other events
Deaths: 4 deaths
From Week 24 to Week 48: Ensifentrine
Serious events: 11 serious events
Other events: 16 other events
Deaths: 2 deaths
From Week 24 to Week 48: Placebo
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Up to Week 24: Ensifentrine
n=477 participants at risk
3 mg twice daily via standard jet nebulizer.
|
Up to Week 24: Placebo
n=283 participants at risk
Twice daily via standard jet nebulizer.
|
From Week 24 to Week 48: Ensifentrine
n=228 participants at risk
3 mg twice daily via standard jet nebulizer (patients that had at least 1 dose after Week 24 visit).
|
From Week 24 to Week 48: Placebo
n=70 participants at risk
Twice daily via standard jet nebulizer (patients that had at least 1 dose after Week 24 visit).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.42%
2/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.71%
2/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.63%
3/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Myocarditis bacterial
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.63%
3/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Pneumonia chlamydial
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
7/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
2.1%
6/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.88%
2/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Shock haemorrhagic
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
Other adverse events
| Measure |
Up to Week 24: Ensifentrine
n=477 participants at risk
3 mg twice daily via standard jet nebulizer.
|
Up to Week 24: Placebo
n=283 participants at risk
Twice daily via standard jet nebulizer.
|
From Week 24 to Week 48: Ensifentrine
n=228 participants at risk
3 mg twice daily via standard jet nebulizer (patients that had at least 1 dose after Week 24 visit).
|
From Week 24 to Week 48: Placebo
n=70 participants at risk
Twice daily via standard jet nebulizer (patients that had at least 1 dose after Week 24 visit).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
5/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
1.3%
6/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.71%
2/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
COVID-19
|
3.4%
16/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
3.2%
9/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.88%
2/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
2.9%
2/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.1%
3/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.44%
1/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
13/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
5.7%
16/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
2.6%
6/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
6/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.8%
5/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.8%
4/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
5/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
5/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.1%
3/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
10/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.35%
1/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.63%
3/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
4/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Nervous system disorders
Headache
|
3.4%
16/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
4.2%
12/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.8%
4/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
2.9%
2/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
3/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
4/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.21%
1/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.1%
3/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
|
Vascular disorders
Hypertension
|
2.3%
11/477 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
1.4%
4/283 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/228 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs; serious or non-serious), were collected from first dose of study medication up to 10 days after final study visit (24-week subset: at Week 24, approximately 25 weeks; 48-week subset: at Week 48, approximately 49 weeks). Serious Adverse Events (SAEs) assessed as related to study participation (eg, change in existing therapy) and which occurred prior to first dose of study medication were collected from time of consent through follow-up contact.
The safety analysis included all randomized patients who received at least 1 dose (or partial dose) of study medication. TEAEs (serious or non-serious) that started or worsened in severity on or after first dose of study medication are reported. SAEs assessed as related to study participation and which occurred prior to first dose of study medication are not reported as it was pre-specified to report only TEAEs that started or worsened in severity on or after first dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place