Trial Outcomes & Findings for VA Augmentation and Switching Treatments for Improving Depression Outcomes (NCT NCT01421342)
NCT ID: NCT01421342
Last Updated: 2018-05-29
Results Overview
Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of \<= 5 for two consecutive visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1522 participants
Primary outcome timeframe
During acute phase (12 weeks)
Results posted on
2018-05-29
Participant Flow
Participant milestones
| Measure |
Switching: Bupropion-SR
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Acute Treatment Phase (12 Weeks)
STARTED
|
511
|
506
|
505
|
|
Acute Treatment Phase (12 Weeks)
COMPLETED
|
353
|
378
|
406
|
|
Acute Treatment Phase (12 Weeks)
NOT COMPLETED
|
158
|
128
|
99
|
|
Completed to Week 12 But Then Withdrawn
STARTED
|
353
|
378
|
406
|
|
Completed to Week 12 But Then Withdrawn
COMPLETED
|
204
|
253
|
268
|
|
Completed to Week 12 But Then Withdrawn
NOT COMPLETED
|
149
|
125
|
138
|
|
Continuation of Treatment (Week 12 - 36)
STARTED
|
204
|
253
|
268
|
|
Continuation of Treatment (Week 12 - 36)
COMPLETED
|
152
|
194
|
203
|
|
Continuation of Treatment (Week 12 - 36)
NOT COMPLETED
|
52
|
59
|
65
|
Reasons for withdrawal
| Measure |
Switching: Bupropion-SR
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Acute Treatment Phase (12 Weeks)
Lack of Efficacy
|
49
|
28
|
13
|
|
Acute Treatment Phase (12 Weeks)
Adverse Event
|
53
|
38
|
27
|
|
Acute Treatment Phase (12 Weeks)
Withdrawal by Subject
|
23
|
20
|
13
|
|
Acute Treatment Phase (12 Weeks)
Death
|
0
|
0
|
3
|
|
Acute Treatment Phase (12 Weeks)
Lost to Follow-up
|
6
|
18
|
21
|
|
Acute Treatment Phase (12 Weeks)
Non-adherence
|
15
|
7
|
13
|
|
Acute Treatment Phase (12 Weeks)
Dure to other illness
|
3
|
2
|
4
|
|
Acute Treatment Phase (12 Weeks)
Participant moved away
|
1
|
6
|
1
|
|
Acute Treatment Phase (12 Weeks)
Other reason for withdrawal
|
8
|
9
|
4
|
|
Completed to Week 12 But Then Withdrawn
Lack of Efficacy
|
111
|
93
|
88
|
|
Completed to Week 12 But Then Withdrawn
QIDS Score >=11
|
7
|
10
|
12
|
|
Completed to Week 12 But Then Withdrawn
Adverse Event
|
4
|
3
|
6
|
|
Completed to Week 12 But Then Withdrawn
Withdrawal by Subject
|
13
|
4
|
11
|
|
Completed to Week 12 But Then Withdrawn
Lost to Follow-up
|
4
|
3
|
3
|
|
Completed to Week 12 But Then Withdrawn
Non-adherence
|
5
|
4
|
5
|
|
Completed to Week 12 But Then Withdrawn
Due to Other Illness
|
1
|
0
|
2
|
|
Completed to Week 12 But Then Withdrawn
Participant Moved Away
|
1
|
5
|
5
|
|
Completed to Week 12 But Then Withdrawn
Oher reason for withdrawal
|
3
|
3
|
4
|
|
Completed to Week 12 But Then Withdrawn
End of Study Time
|
0
|
0
|
2
|
|
Continuation of Treatment (Week 12 - 36)
Lack of Efficacy
|
11
|
5
|
11
|
|
Continuation of Treatment (Week 12 - 36)
Adverse Event
|
0
|
6
|
11
|
|
Continuation of Treatment (Week 12 - 36)
Withdrawal by Subject
|
7
|
6
|
4
|
|
Continuation of Treatment (Week 12 - 36)
Lost to Follow-up
|
4
|
11
|
9
|
|
Continuation of Treatment (Week 12 - 36)
Non-adherence
|
3
|
8
|
4
|
|
Continuation of Treatment (Week 12 - 36)
End of Study Time
|
15
|
20
|
14
|
|
Continuation of Treatment (Week 12 - 36)
Participant moved away
|
4
|
1
|
3
|
|
Continuation of Treatment (Week 12 - 36)
Due to Other Illness
|
2
|
2
|
2
|
|
Continuation of Treatment (Week 12 - 36)
Other reason for withdrawal
|
6
|
0
|
7
|
Baseline Characteristics
Assessments missing for two participants at baseline.
Baseline characteristics by cohort
| Measure |
Switching: Bupropion-SR
n=511 Participants
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 Participants
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 Participants
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Total
n=1522 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 12.2 • n=511 Participants
|
54.4 years
STANDARD_DEVIATION 12.2 • n=506 Participants
|
54.2 years
STANDARD_DEVIATION 12.3 • n=505 Participants
|
54.4 years
STANDARD_DEVIATION 12.2 • n=1522 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=511 Participants
|
81 Participants
n=506 Participants
|
77 Participants
n=505 Participants
|
226 Participants
n=1522 Participants
|
|
Sex: Female, Male
Male
|
443 Participants
n=511 Participants
|
425 Participants
n=506 Participants
|
428 Participants
n=505 Participants
|
1296 Participants
n=1522 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=511 Participants
|
2 Participants
n=506 Participants
|
1 Participants
n=505 Participants
|
3 Participants
n=1522 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
454 Participants
n=511 Participants
|
449 Participants
n=506 Participants
|
459 Participants
n=505 Participants
|
1362 Participants
n=1522 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=511 Participants
|
55 Participants
n=506 Participants
|
45 Participants
n=505 Participants
|
157 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=511 Participants
|
8 Participants
n=506 Participants
|
6 Participants
n=505 Participants
|
22 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=511 Participants
|
1 Participants
n=506 Participants
|
4 Participants
n=505 Participants
|
7 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=511 Participants
|
2 Participants
n=506 Participants
|
1 Participants
n=505 Participants
|
5 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
Black or African American
|
129 Participants
n=511 Participants
|
115 Participants
n=506 Participants
|
126 Participants
n=505 Participants
|
370 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=511 Participants
|
343 Participants
n=506 Participants
|
338 Participants
n=505 Participants
|
1022 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=511 Participants
|
20 Participants
n=506 Participants
|
13 Participants
n=505 Participants
|
43 Participants
n=1522 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=511 Participants
|
17 Participants
n=506 Participants
|
17 Participants
n=505 Participants
|
53 Participants
n=1522 Participants
|
|
QIDS-C16 Score
|
16.6 units on a scale
STANDARD_DEVIATION 3.3 • n=511 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 3.2 • n=506 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 3.3 • n=505 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 3.3 • n=1522 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
15.9 units on a scale
STANDARD_DEVIATION 5.2 • n=511 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 5.2 • n=506 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 5.2 • n=505 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 5.2 • n=1522 Participants
|
|
CGI - Severity Score
|
4.5 units on a scale
STANDARD_DEVIATION 1.0 • n=510 Participants • Assessments missing for two participants at baseline.
|
4.6 units on a scale
STANDARD_DEVIATION 0.9 • n=505 Participants • Assessments missing for two participants at baseline.
|
4.6 units on a scale
STANDARD_DEVIATION 1.0 • n=505 Participants • Assessments missing for two participants at baseline.
|
4.6 units on a scale
STANDARD_DEVIATION 1.0 • n=1520 Participants • Assessments missing for two participants at baseline.
|
|
Beck Anxiety Inventory
|
18.6 units on a scale
STANDARD_DEVIATION 11.1 • n=510 Participants • Assessment missing for three participants at baseline
|
19.0 units on a scale
STANDARD_DEVIATION 11.4 • n=506 Participants • Assessment missing for three participants at baseline
|
19.7 units on a scale
STANDARD_DEVIATION 11.3 • n=503 Participants • Assessment missing for three participants at baseline
|
19.1 units on a scale
STANDARD_DEVIATION 11.3 • n=1519 Participants • Assessment missing for three participants at baseline
|
|
Arizona Sexual Experiences Scale (Female)
|
4.2 participants
STANDARD_DEVIATION 1.1 • n=64 Participants • The ASEX (female) version of the questionnaire was specific to females. Not all females completed the questionnaire, therefore, the number of responders is lower than number of female participants due to missing responses.
|
4.2 participants
STANDARD_DEVIATION 1.1 • n=76 Participants • The ASEX (female) version of the questionnaire was specific to females. Not all females completed the questionnaire, therefore, the number of responders is lower than number of female participants due to missing responses.
|
4.2 participants
STANDARD_DEVIATION 1.2 • n=73 Participants • The ASEX (female) version of the questionnaire was specific to females. Not all females completed the questionnaire, therefore, the number of responders is lower than number of female participants due to missing responses.
|
4.2 participants
STANDARD_DEVIATION 1.1 • n=213 Participants • The ASEX (female) version of the questionnaire was specific to females. Not all females completed the questionnaire, therefore, the number of responders is lower than number of female participants due to missing responses.
|
|
Arizona Sexual Experiences Scale (male)
|
4.1 participants
STANDARD_DEVIATION 1.1 • n=434 Participants • The ASEX (male) version of the questionnaire was specific to males. Not all males completed the questionnaire, therefore, the number of responders is lower than number of male participants due to missing responses.
|
4.1 participants
STANDARD_DEVIATION 1.1 • n=418 Participants • The ASEX (male) version of the questionnaire was specific to males. Not all males completed the questionnaire, therefore, the number of responders is lower than number of male participants due to missing responses.
|
4.1 participants
STANDARD_DEVIATION 1.2 • n=421 Participants • The ASEX (male) version of the questionnaire was specific to males. Not all males completed the questionnaire, therefore, the number of responders is lower than number of male participants due to missing responses.
|
4.1 participants
STANDARD_DEVIATION 1.1 • n=1273 Participants • The ASEX (male) version of the questionnaire was specific to males. Not all males completed the questionnaire, therefore, the number of responders is lower than number of male participants due to missing responses.
|
|
PTSD
|
248 Participants
n=511 Participants
|
244 Participants
n=506 Participants
|
225 Participants
n=505 Participants
|
717 Participants
n=1522 Participants
|
|
EuroQol Health State Score
|
54.7 units on a scale
STANDARD_DEVIATION 20.5 • n=511 Participants • Assessment missing for one participant at baseline
|
52.7 units on a scale
STANDARD_DEVIATION 19.8 • n=505 Participants • Assessment missing for one participant at baseline
|
54.0 units on a scale
STANDARD_DEVIATION 20.8 • n=505 Participants • Assessment missing for one participant at baseline
|
53.8 units on a scale
STANDARD_DEVIATION 20.4 • n=1521 Participants • Assessment missing for one participant at baseline
|
|
Quality of Life Enjoyment and Satisfaction Score
|
41.4 units on a scale
STANDARD_DEVIATION 13.8 • n=511 Participants
|
40.3 units on a scale
STANDARD_DEVIATION 14.8 • n=506 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 14.8 • n=505 Participants
|
40.6 units on a scale
STANDARD_DEVIATION 14.5 • n=1522 Participants
|
|
Cumulative Illness Rating Scale (CIRS) Severity Index
|
11.4 units on a scale
STANDARD_DEVIATION 5.5 • n=511 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 4.9 • n=506 Participants
|
11.0 units on a scale
STANDARD_DEVIATION 5.1 • n=505 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 5.2 • n=1522 Participants
|
PRIMARY outcome
Timeframe: During acute phase (12 weeks)Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of \<= 5 for two consecutive visits.
Outcome measures
| Measure |
Switching: Bupropion-SR
n=511 Participants
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 Participants
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 Participants
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Rate of Protocol Remission of Symptoms of Major Depressive Disorder
|
114 Participants
|
136 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: Within 36 weeks after randomization (initiation of treatment)Population: The Analysis Population is the cohort of participants who met the criteria for protocol remission during the Acute Phase (first 12 Weeks of follow-up)
Relapse in symptoms of major depression defined as a QIDS-C16 =\> 11 among those achieving remission in the acute phase.
Outcome measures
| Measure |
Switching: Bupropion-SR
n=114 Participants
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=136 Participants
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=146 Participants
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase
|
26 Participants
|
35 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: During acute phase (up to 12 weeks)Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater
Outcome measures
| Measure |
Switching: Bupropion-SR
n=511 Participants
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 Participants
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 Participants
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)
|
319 Participants
|
332 Participants
|
375 Participants
|
SECONDARY outcome
Timeframe: During acute phase (up to 12 weeks)Population: Whole randomized cohort by intent-to-treat
Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved).
Outcome measures
| Measure |
Switching: Bupropion-SR
n=511 Participants
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 Participants
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 Participants
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale
|
356 Participants
|
376 Participants
|
400 Participants
|
Adverse Events
Switching: Bupropion-SR
Serious events: 52 serious events
Other events: 383 other events
Deaths: 3 deaths
Augmenting: Antidepressant + Bupropion-SR
Serious events: 57 serious events
Other events: 369 other events
Deaths: 1 deaths
Augmenting: Antidepressant + Aripiprazole
Serious events: 56 serious events
Other events: 374 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Switching: Bupropion-SR
n=511 participants at risk
Switching: Bupropion-SR
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 participants at risk
Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 participants at risk
Augmenting: Antidepressant + Aripiprazole
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Psychiatric disorders
Psychiatric disorders (total)
|
2.9%
15/511 • Number of events 15 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.8%
14/506 • Number of events 17 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.6%
13/505 • Number of events 16 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Alcohol abuse
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/505 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Completed suicide
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Delirium
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Self-injurious ideation
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Somatisation disorder
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
8/511 • Number of events 8 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/506 • Number of events 11 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.99%
5/505 • Number of events 5 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.59%
3/511 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Nervous system disorders (total)
|
1.4%
7/511 • Number of events 7 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/506 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Drug withdrawal headache
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Seizure
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/505 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorders (total)
|
0.59%
3/511 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/505 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Endocrine disorders
Hyperaldosteronism
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
General disorders and administration site conditions (total)
|
0.78%
4/511 • Number of events 6 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.99%
5/505 • Number of events 6 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Adverse drug reaction
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Asthenia
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Chest pain
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Device malfunction
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Hernia obstructive
|
0.20%
1/511 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
Sudden death
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Cardiac disorders (total)
|
1.4%
7/511 • Number of events 7 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.79%
4/506 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.6%
8/505 • Number of events 8 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/505 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Vascular disorders
Arterial occlusive disease
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Infections and infestations (total)
|
1.2%
6/511 • Number of events 6 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/506 • Number of events 11 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.4%
12/505 • Number of events 14 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Abscess
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Pneumonia
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.79%
4/506 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Sinusitis
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Surgical and medical procedures
Drug detoxification
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
Other adverse events
| Measure |
Switching: Bupropion-SR
n=511 participants at risk
Switching: Bupropion-SR
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Bupropion-SR
n=506 participants at risk
Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
And
Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
Augmenting: Antidepressant + Aripiprazole
n=505 participants at risk
Augmenting: Antidepressant + Aripiprazole
Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
And
Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Cardiac disorders
Cardiac disorders
|
0.78%
4/511 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.40%
2/506 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
—
0/0 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.78%
4/511 • Number of events 4 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.2%
11/506 • Number of events 12 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Eye disorders
Eye disorders
|
0.98%
5/511 • Number of events 5 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/506 • Number of events 10 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.4%
12/505 • Number of events 14 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
37.0%
189/511 • Number of events 305 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
31.0%
157/506 • Number of events 288 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
29.1%
147/505 • Number of events 230 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
General disorders
General disorders and administration site conditions
|
16.0%
82/511 • Number of events 100 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
14.4%
73/506 • Number of events 97 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
20.8%
105/505 • Number of events 115 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.20%
1/511 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Infections and infestations
Infections and infestations
|
3.9%
20/511 • Number of events 21 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/506 • Number of events 13 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.2%
11/505 • Number of events 12 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.2%
11/506 • Number of events 12 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.8%
9/505 • Number of events 10 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Investigations
Investigations
|
4.9%
25/511 • Number of events 28 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
7.5%
38/506 • Number of events 41 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
14.3%
72/505 • Number of events 81 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
22.3%
114/511 • Number of events 134 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
18.8%
95/506 • Number of events 111 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
22.4%
113/505 • Number of events 142 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
3.9%
20/511 • Number of events 21 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/506 • Number of events 10 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
3.4%
17/505 • Number of events 20 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.39%
2/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/506 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/505 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Nervous system disorders
Nervous system disorders
|
42.7%
218/511 • Number of events 383 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
46.4%
235/506 • Number of events 426 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
47.3%
239/505 • Number of events 433 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Psychiatric disorders
Psychiatric disorders
|
43.8%
224/511 • Number of events 393 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
39.5%
200/506 • Number of events 349 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
100.0%
176/176 • Number of events 270 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.6%
8/511 • Number of events 8 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.8%
9/506 • Number of events 10 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.2%
6/505 • Number of events 6 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.20%
1/511 • Number of events 2 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.8%
9/506 • Number of events 9 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
1.4%
7/505 • Number of events 7 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.0%
10/511 • Number of events 11 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.99%
5/506 • Number of events 5 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
2.0%
10/505 • Number of events 12 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
9.8%
50/511 • Number of events 63 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
9.5%
48/506 • Number of events 58 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
7.5%
38/505 • Number of events 45 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Social circumstances
Social circumstances
|
0.00%
0/511 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.00%
0/506 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.20%
1/505 • Number of events 1 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
|
Vascular disorders
Vascular disorders
|
1.4%
7/511 • Number of events 8 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/506 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
0.59%
3/505 • Number of events 3 • Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
|
Additional Information
Gary R. Johnson, MS
VA Cooperative Studies Program Coordinating Center, West Haven, CT
Phone: (203) 932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place