Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder (NCT NCT02191397)
NCT ID: NCT02191397
Last Updated: 2020-02-25
Results Overview
HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is \>=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
534 participants
Primary outcome timeframe
Baseline (Week 0) and Week 8
Results posted on
2020-02-25
Participant Flow
This was a multi-center, randomized, double-blind, parallel active-controlled study to evaluate the efficacy, safety and tolerability of bupropion hydrochloride extended-release (XL) and escitalopram oxalate in participants with major depressive disorder. This study was conducted in China from 10-February-2015 to 25-October-2016.
The study had screening phase (up to 14 days), 8-week double blind treatment phase and taper phase (up to 1 week). A total of 655 participants were screened and 538 were randomized into the study. 4 participants were randomized but discontinued prior to receiving any study treatment. Hence, the Safety Population was comprised of 534 participants.
Participant milestones
| Measure |
Bupropion XL
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Overall Study
STARTED
|
266
|
268
|
|
Overall Study
COMPLETED
|
183
|
198
|
|
Overall Study
NOT COMPLETED
|
83
|
70
|
Reasons for withdrawal
| Measure |
Bupropion XL
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Overall Study
Adverse Event
|
28
|
17
|
|
Overall Study
Lack of Efficacy
|
10
|
5
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Met protocol-defined stopping criteria
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
|
Overall Study
Physician Decision
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
22
|
27
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Total
n=534 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
36.9 Years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
37.6 Years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
37.3 Years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
266 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
534 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 8Population: PP Population
HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is \>=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed.
Outcome measures
| Measure |
Bupropion XL
n=176 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=188 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
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Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)
|
-14.5 Scores on a scale
Standard Error 0.41
|
-15.4 Scores on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
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Response Rate Based on HAMD-17 Total Score
|
69.6 Percentage of Participants
|
72.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Remission was defined as HAMD-17 total scores at end of acute treatment phase (Week 8) \<=7.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Remission Rate Based on HAMD-17 Total Score
|
39.7 Percentage of Participants
|
47.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Sustained Response Rate Based on HAMD-17 Total Score
|
51.6 Percentage of Participants
|
56.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits \<=8.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Sustained Remission Rate Based on HAMD-17 Total Score
|
25.5 Percentage of Participants
|
28.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
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|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-3.6 Scores on a scale
Standard Error 0.34
|
-3.8 Scores on a scale
Standard Error 0.33
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-7.0 Scores on a scale
Standard Error 0.47
|
-8.3 Scores on a scale
Standard Error 0.45
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-11.2 Scores on a scale
Standard Error 0.58
|
-12.4 Scores on a scale
Standard Error 0.56
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 196
|
-15.5 Scores on a scale
Standard Error 0.59
|
-16.3 Scores on a scale
Standard Error 0.57
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-18.6 Scores on a scale
Standard Error 0.57
|
-19.5 Scores on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-0.4 Scores on a scale
Standard Deviation 0.04
|
-0.4 Scores on a scale
Standard Deviation 0.04
|
|
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-0.7 Scores on a scale
Standard Deviation 0.06
|
-0.8 Scores on a scale
Standard Deviation 0.05
|
|
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-1.1 Scores on a scale
Standard Deviation 0.06
|
-1.3 Scores on a scale
Standard Deviation 0.06
|
|
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
-1.5 Scores on a scale
Standard Deviation 0.06
|
-1.6 Scores on a scale
Standard Deviation 0.06
|
|
Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-1.9 Scores on a scale
Standard Deviation 0.06
|
-1.9 Scores on a scale
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-1.3 Scores on a scale
Standard Error 0.12
|
-1.1 Scores on a scale
Standard Error 0.12
|
|
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-2.0 Scores on a scale
Standard Error 0.15
|
-2.4 Scores on a scale
Standard Error 0.14
|
|
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-3.0 Scores on a scale
Standard Error 0.19
|
-3.4 Scores on a scale
Standard Error 0.18
|
|
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
-4.0 Scores on a scale
Standard Error 0.17
|
-4.4 Scores on a scale
Standard Error 0.17
|
|
Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-4.8 Scores on a scale
Standard Error 0.16
|
-5.1 Scores on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-2.9 Scores on a scale
Standard Error 0.15
|
-3.1 Scores on a scale
Standard Error 0.15
|
|
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
-3.9 Scores on a scale
Standard Error 0.16
|
-3.9 Scores on a scale
Standard Error 0.16
|
|
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-4.7 Scores on a scale
Standard Error 0.17
|
-4.9 Scores on a scale
Standard Error 0.16
|
|
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-1.0 Scores on a scale
Standard Error 0.10
|
-1.0 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-1.8 Scores on a scale
Standard Error 0.13
|
-2.0 Scores on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-0.6 Scores on a scale
Standard Error 0.10
|
-0.7 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-0.8 Scores on a scale
Standard Error 0.11
|
-1.2 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-1.4 Scores on a scale
Standard Error 0.11
|
-1.6 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
-1.8 Scores on a scale
Standard Error 0.11
|
-2.0 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-2.3 Scores on a scale
Standard Error 0.11
|
-2.4 Scores on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing "Not assessed" were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
-0.3 Scores on a scale
Standard Error 0.04
|
-0.4 Scores on a scale
Standard Error 0.04
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
-0.7 Scores on a scale
Standard Error 0.05
|
-0.8 Scores on a scale
Standard Error 0.05
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
-1.1 Scores on a scale
Standard Error 0.07
|
-1.3 Scores on a scale
Standard Error 0.06
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
-1.6 Scores on a scale
Standard Error 0.07
|
-1.7 Scores on a scale
Standard Error 0.07
|
|
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
-2.1 Scores on a scale
Standard Error 0.07
|
-2.2 Scores on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8Population: PP Population
For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents "Not assessed", and the remaining values 1-7 represent "Very much improved" (1) to "Very much worse" (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.
Outcome measures
| Measure |
Bupropion XL
n=184 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=199 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8
Week 1, n=184, 199
|
6 Percentage of Participants
|
7.5 Percentage of Participants
|
|
Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8
Week 2, n=182, 199
|
21.4 Percentage of Participants
|
22.1 Percentage of Participants
|
|
Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8
Week 4, n=184, 198
|
38.6 Percentage of Participants
|
52.5 Percentage of Participants
|
|
Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8
Week 6, n=183, 197
|
67.8 Percentage of Participants
|
71.6 Percentage of Participants
|
|
Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 4, 6 and 8
Week 8, n=176, 188
|
80.7 Percentage of Participants
|
83.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication.
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)
Any non-serious AE
|
151 Participants
|
150 Participants
|
|
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)
Any SAE
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Hemoglobin, Week 8, n=176, 183
|
-0.22 Gram per Liter (G/L)
Standard Deviation 7.621
|
-1.16 Gram per Liter (G/L)
Standard Deviation 7.874
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Hemoglobin, Taper, n=13, 16
|
-1.54 Gram per Liter (G/L)
Standard Deviation 5.868
|
1.38 Gram per Liter (G/L)
Standard Deviation 8.057
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Hemoglobin, Follow-up, n=10, 8
|
-3.10 Gram per Liter (G/L)
Standard Deviation 12.449
|
0.38 Gram per Liter (G/L)
Standard Deviation 6.163
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Total protein, Week 8, n=174, 183
|
-0.640 Gram per Liter (G/L)
Standard Deviation 5.2784
|
-0.891 Gram per Liter (G/L)
Standard Deviation 4.0339
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Total protein, Taper, n=12, 15
|
1.197 Gram per Liter (G/L)
Standard Deviation 6.9347
|
2.000 Gram per Liter (G/L)
Standard Deviation 8.7513
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Total protein, Follow-up, n=8, 12
|
-4.650 Gram per Liter (G/L)
Standard Deviation 5.5131
|
-1.227 Gram per Liter (G/L)
Standard Deviation 4.8619
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Albumin, Week 8, n=175, 183
|
-0.254 Gram per Liter (G/L)
Standard Deviation 3.0207
|
-0.678 Gram per Liter (G/L)
Standard Deviation 2.8483
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Albumin, Taper, n=12, 15
|
-0.086 Gram per Liter (G/L)
Standard Deviation 3.9688
|
-0.027 Gram per Liter (G/L)
Standard Deviation 4.2372
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
Albumin, Follow-up, n=8, 12
|
-1.925 Gram per Liter (G/L)
Standard Deviation 2.0084
|
-1.577 Gram per Liter (G/L)
Standard Deviation 3.6313
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
MCHC, Week 8, n=176, 183
|
-0.09 Gram per Liter (G/L)
Standard Deviation 8.933
|
0.76 Gram per Liter (G/L)
Standard Deviation 9.821
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
MCHC, Taper, n=13, 16
|
0.54 Gram per Liter (G/L)
Standard Deviation 8.828
|
2.25 Gram per Liter (G/L)
Standard Deviation 9.030
|
|
Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
MCHC, Follow-up, n=10, 8
|
-2.10 Gram per Liter (G/L)
Standard Deviation 9.398
|
-2.88 Gram per Liter (G/L)
Standard Deviation 5.055
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Week 8, n=176, 183
|
0.0016 Proportion of red blood cells in blood
Standard Deviation 0.06088
|
-0.0044 Proportion of red blood cells in blood
Standard Deviation 0.02587
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Taper, n=13, 16
|
-0.0051 Proportion of red blood cells in blood
Standard Deviation 0.02105
|
0.0017 Proportion of red blood cells in blood
Standard Deviation 0.02601
|
|
Change From Baseline in Hematocrit at the Indicated Time Points
Hematocrit, Follow-up, n=10, 8
|
-0.0076 Proportion of red blood cells in blood
Standard Deviation 0.04403
|
0.0051 Proportion of red blood cells in blood
Standard Deviation 0.01509
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
WBC count, Week 8, n=176, 183
|
-0.032 Giga cells per liter (GI/L)
Standard Deviation 1.6278
|
-0.073 Giga cells per liter (GI/L)
Standard Deviation 1.6282
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
WBC count, Taper, n=13, 16
|
0.065 Giga cells per liter (GI/L)
Standard Deviation 1.5513
|
-0.715 Giga cells per liter (GI/L)
Standard Deviation 1.8547
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
WBC count, Follow-up, n=10, 8
|
-0.743 Giga cells per liter (GI/L)
Standard Deviation 1.4455
|
0.427 Giga cells per liter (GI/L)
Standard Deviation 0.9032
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Total Neutrophils, Week 8, n=176, 183
|
0.101 Giga cells per liter (GI/L)
Standard Deviation 1.4835
|
-0.165 Giga cells per liter (GI/L)
Standard Deviation 1.5540
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Total Neutrophils, Taper, n=13, 16
|
0.306 Giga cells per liter (GI/L)
Standard Deviation 1.6222
|
-0.772 Giga cells per liter (GI/L)
Standard Deviation 1.5656
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Total Neutrophils, Follow-up, n=10, 8
|
-0.869 Giga cells per liter (GI/L)
Standard Deviation 1.4578
|
0.424 Giga cells per liter (GI/L)
Standard Deviation 0.7470
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Lymphocytes, Week 8, n=176, 183
|
-0.154 Giga cells per liter (GI/L)
Standard Deviation 0.4833
|
0.072 Giga cells per liter (GI/L)
Standard Deviation 0.4190
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Lymphocytes, Taper, n=13, 16
|
-0.242 Giga cells per liter (GI/L)
Standard Deviation 0.4843
|
0.077 Giga cells per liter (GI/L)
Standard Deviation 0.5053
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Lymphocytes, Follow-up, n=10, 8
|
0.042 Giga cells per liter (GI/L)
Standard Deviation 0.3937
|
0.022 Giga cells per liter (GI/L)
Standard Deviation 0.4388
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Basophil, Week 8, n=176, 182
|
0.001 Giga cells per liter (GI/L)
Standard Deviation 0.0173
|
0.002 Giga cells per liter (GI/L)
Standard Deviation 0.0218
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Basophil, Taper, n=13, 16
|
0.001 Giga cells per liter (GI/L)
Standard Deviation 0.0091
|
0.001 Giga cells per liter (GI/L)
Standard Deviation 0.0131
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Basophil, Follow-up, n=10, 8
|
-0.003 Giga cells per liter (GI/L)
Standard Deviation 0.0163
|
-0.012 Giga cells per liter (GI/L)
Standard Deviation 0.0087
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Eosinophil, Week 8, n=176, 182
|
-0.004 Giga cells per liter (GI/L)
Standard Deviation 0.0788
|
0.010 Giga cells per liter (GI/L)
Standard Deviation 0.0899
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Eosinophil, Taper, n=13, 16
|
-0.012 Giga cells per liter (GI/L)
Standard Deviation 0.0592
|
0.006 Giga cells per liter (GI/L)
Standard Deviation 0.0488
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Eosinophil, Follow-up, n=10, 8
|
-0.005 Giga cells per liter (GI/L)
Standard Deviation 0.0627
|
0.019 Giga cells per liter (GI/L)
Standard Deviation 0.0813
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Monocyte, Week 8, n=176, 182
|
0.021 Giga cells per liter (GI/L)
Standard Deviation 0.1180
|
0.003 Giga cells per liter (GI/L)
Standard Deviation 0.1113
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Monocyte, Taper, n=13, 16
|
-0.001 Giga cells per liter (GI/L)
Standard Deviation 0.1023
|
-0.031 Giga cells per liter (GI/L)
Standard Deviation 0.0917
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Monocyte, Follow-up, n=10, 8
|
0.058 Giga cells per liter (GI/L)
Standard Deviation 0.1292
|
0.010 Giga cells per liter (GI/L)
Standard Deviation 0.0920
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Platelet count, Week 8, n=176, 183
|
7.73 Giga cells per liter (GI/L)
Standard Deviation 32.725
|
0.56 Giga cells per liter (GI/L)
Standard Deviation 29.492
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Platelet count, Taper, n=13, 16
|
17.15 Giga cells per liter (GI/L)
Standard Deviation 35.126
|
7.19 Giga cells per liter (GI/L)
Standard Deviation 22.448
|
|
Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
Platelet count, Follow-up, n=10, 8
|
28.50 Giga cells per liter (GI/L)
Standard Deviation 35.600
|
5.38 Giga cells per liter (GI/L)
Standard Deviation 24.784
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin, Week 8, n=175, 181
|
-0.812 Micromoles per liter (µmol/L)
Standard Deviation 4.7591
|
-0.071 Micromoles per liter (µmol/L)
Standard Deviation 4.8022
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin, Taper, n=12, 15
|
-3.457 Micromoles per liter (µmol/L)
Standard Deviation 6.5521
|
1.198 Micromoles per liter (µmol/L)
Standard Deviation 3.9442
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Total bilirubin, Follow-up, n=8, 12
|
0.382 Micromoles per liter (µmol/L)
Standard Deviation 4.0151
|
0.338 Micromoles per liter (µmol/L)
Standard Deviation 3.4710
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Direct bilirubin, Week 8, n=175, 180
|
-0.072 Micromoles per liter (µmol/L)
Standard Deviation 1.3659
|
-0.006 Micromoles per liter (µmol/L)
Standard Deviation 1.2310
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Direct bilirubin, Taper, n=11, 15
|
-1.554 Micromoles per liter (µmol/L)
Standard Deviation 3.7607
|
0.654 Micromoles per liter (µmol/L)
Standard Deviation 1.7145
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Direct bilirubin, Follow-up, n=8, 12
|
-0.102 Micromoles per liter (µmol/L)
Standard Deviation 1.1192
|
0.382 Micromoles per liter (µmol/L)
Standard Deviation 0.9070
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Week 8, n=174, 183
|
7.507 Micromoles per liter (µmol/L)
Standard Deviation 10.6852
|
0.307 Micromoles per liter (µmol/L)
Standard Deviation 9.0811
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Taper, n=12, 15
|
6.675 Micromoles per liter (µmol/L)
Standard Deviation 6.9134
|
0.880 Micromoles per liter (µmol/L)
Standard Deviation 10.3281
|
|
Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
Creatinine, Follow-up, n=8, 11
|
4.237 Micromoles per liter (µmol/L)
Standard Deviation 8.9291
|
1.618 Micromoles per liter (µmol/L)
Standard Deviation 9.6668
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALT, Week 8, n=176, 183
|
2.254 International Units per liter (IU/L)
Standard Deviation 14.7208
|
1.315 International Units per liter (IU/L)
Standard Deviation 10.3019
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALT, Taper, n=12, 16
|
7.993 International Units per liter (IU/L)
Standard Deviation 17.5985
|
-1.812 International Units per liter (IU/L)
Standard Deviation 15.1544
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALT, Follow-up, n=8, 12
|
-7.337 International Units per liter (IU/L)
Standard Deviation 21.7809
|
5.938 International Units per liter (IU/L)
Standard Deviation 19.8234
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALP, Week 8, n=176, 181
|
1.866 International Units per liter (IU/L)
Standard Deviation 13.2776
|
0.407 International Units per liter (IU/L)
Standard Deviation 11.7870
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALP, Taper, n=12, 15
|
3.674 International Units per liter (IU/L)
Standard Deviation 11.5803
|
3.480 International Units per liter (IU/L)
Standard Deviation 19.2823
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
ALP, Follow-up, n=7, 12
|
5.643 International Units per liter (IU/L)
Standard Deviation 9.2858
|
-3.953 International Units per liter (IU/L)
Standard Deviation 11.6377
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
AST, Week 8, n=176, 183
|
0.330 International Units per liter (IU/L)
Standard Deviation 7.6259
|
1.099 International Units per liter (IU/L)
Standard Deviation 6.1029
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
AST, Taper, n=12, 16
|
3.193 International Units per liter (IU/L)
Standard Deviation 7.4990
|
0.381 International Units per liter (IU/L)
Standard Deviation 6.0938
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
AST, Follow-up, n=8, 12
|
0.925 International Units per liter (IU/L)
Standard Deviation 23.3485
|
2.867 International Units per liter (IU/L)
Standard Deviation 11.0264
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
GGT, Week 8, n=175, 181
|
0.688 International Units per liter (IU/L)
Standard Deviation 17.0699
|
-0.694 International Units per liter (IU/L)
Standard Deviation 11.1878
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
GGT, Taper, n=12, 15
|
1.403 International Units per liter (IU/L)
Standard Deviation 6.2977
|
-3.133 International Units per liter (IU/L)
Standard Deviation 4.8019
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
GGT, Follow-up, n=7, 12
|
-2.029 International Units per liter (IU/L)
Standard Deviation 5.9637
|
3.916 International Units per liter (IU/L)
Standard Deviation 25.9888
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
LD, Week 8, n=176, 182
|
1.292 International Units per liter (IU/L)
Standard Deviation 32.4627
|
2.879 International Units per liter (IU/L)
Standard Deviation 27.3838
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
LD, Taper, n=13, 13
|
14.463 International Units per liter (IU/L)
Standard Deviation 28.9571
|
-8.092 International Units per liter (IU/L)
Standard Deviation 55.0095
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
LD, Follow-up, n=8, 10
|
11.037 International Units per liter (IU/L)
Standard Deviation 45.3316
|
-4.150 International Units per liter (IU/L)
Standard Deviation 33.8871
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Calcium, Taper, n=12, 12
|
-0.019 Millimole per liter (mmol/L)
Standard Deviation 0.1906
|
0.012 Millimole per liter (mmol/L)
Standard Deviation 0.1091
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Calcium, Week 8, n=173, 183
|
-0.017 Millimole per liter (mmol/L)
Standard Deviation 0.1139
|
-0.020 Millimole per liter (mmol/L)
Standard Deviation 0.1225
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Calcium, Follow-up, n=8, 11
|
-0.060 Millimole per liter (mmol/L)
Standard Deviation 0.1032
|
-0.060 Millimole per liter (mmol/L)
Standard Deviation 0.1352
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Chloride, Week 8, n=173, 182
|
0.259 Millimole per liter (mmol/L)
Standard Deviation 2.7943
|
-0.293 Millimole per liter (mmol/L)
Standard Deviation 2.5913
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Chloride, Taper, n=10, 13
|
-0.498 Millimole per liter (mmol/L)
Standard Deviation 3.2001
|
-0.566 Millimole per liter (mmol/L)
Standard Deviation 2.4684
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Chloride, Follow-up, n=8, 8
|
-0.287 Millimole per liter (mmol/L)
Standard Deviation 3.6588
|
-0.178 Millimole per liter (mmol/L)
Standard Deviation 4.6453
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Cholesterol, Week 8, n=175, 181
|
-0.122 Millimole per liter (mmol/L)
Standard Deviation 0.5855
|
0.051 Millimole per liter (mmol/L)
Standard Deviation 0.5931
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Cholesterol, Taper, n=12, 14
|
0.022 Millimole per liter (mmol/L)
Standard Deviation 0.5891
|
0.082 Millimole per liter (mmol/L)
Standard Deviation 0.5991
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Cholesterol, Follow-up, n=9, 11
|
-0.124 Millimole per liter (mmol/L)
Standard Deviation 0.5149
|
-0.122 Millimole per liter (mmol/L)
Standard Deviation 0.5899
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Glucose, Week 8, n=173, 181
|
-0.051 Millimole per liter (mmol/L)
Standard Deviation 0.6327
|
-0.050 Millimole per liter (mmol/L)
Standard Deviation 0.5871
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Glucose, Taper, n=12, 16
|
0.352 Millimole per liter (mmol/L)
Standard Deviation 0.3822
|
0.106 Millimole per liter (mmol/L)
Standard Deviation 0.9661
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Glucose, Follow-up, n=9, 11
|
-0.194 Millimole per liter (mmol/L)
Standard Deviation 0.4089
|
0.025 Millimole per liter (mmol/L)
Standard Deviation 1.2117
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Potassium, Week 8, n=173, 182
|
-0.021 Millimole per liter (mmol/L)
Standard Deviation 0.3504
|
0.009 Millimole per liter (mmol/L)
Standard Deviation 0.3552
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Potassium, Taper, n=10, 13
|
-0.114 Millimole per liter (mmol/L)
Standard Deviation 0.4165
|
0.046 Millimole per liter (mmol/L)
Standard Deviation 0.5095
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Potassium, Follow-up, n=8, 8
|
-0.110 Millimole per liter (mmol/L)
Standard Deviation 0.6221
|
0.036 Millimole per liter (mmol/L)
Standard Deviation 0.6556
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Sodium, Week 8, n=173, 182
|
-0.205 Millimole per liter (mmol/L)
Standard Deviation 2.4757
|
-0.178 Millimole per liter (mmol/L)
Standard Deviation 2.5481
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Sodium, Taper, n=10, 13
|
-0.611 Millimole per liter (mmol/L)
Standard Deviation 3.0799
|
0.978 Millimole per liter (mmol/L)
Standard Deviation 1.5853
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Sodium, Follow-up, n=8, 8
|
-0.175 Millimole per liter (mmol/L)
Standard Deviation 3.9085
|
0.770 Millimole per liter (mmol/L)
Standard Deviation 3.6011
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Triglycerides, Week 8, n=175, 181
|
0.003 Millimole per liter (mmol/L)
Standard Deviation 1.0499
|
0.022 Millimole per liter (mmol/L)
Standard Deviation 0.5844
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Triglycerides, Taper, n=13, 15
|
-0.032 Millimole per liter (mmol/L)
Standard Deviation 0.4359
|
0.574 Millimole per liter (mmol/L)
Standard Deviation 2.0355
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Triglycerides, Follow-up, n=9, 11
|
0.637 Millimole per liter (mmol/L)
Standard Deviation 1.4045
|
0.181 Millimole per liter (mmol/L)
Standard Deviation 0.7767
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Urea, Week 8, n=174, 183
|
-0.068 Millimole per liter (mmol/L)
Standard Deviation 1.3282
|
0.015 Millimole per liter (mmol/L)
Standard Deviation 1.1723
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Urea, Taper, n=12, 16
|
0.517 Millimole per liter (mmol/L)
Standard Deviation 0.9249
|
-0.269 Millimole per liter (mmol/L)
Standard Deviation 1.0223
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
Urea, Follow-up, n=8, 11
|
0.687 Millimole per liter (mmol/L)
Standard Deviation 0.6998
|
-0.419 Millimole per liter (mmol/L)
Standard Deviation 1.0801
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points
MCH, Week 8, n=176, 183
|
-0.032 Picograms
Standard Deviation 0.7431
|
0.049 Picograms
Standard Deviation 0.7052
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points
MCH, Taper, n=13, 16
|
0.269 Picograms
Standard Deviation 0.7941
|
0.262 Picograms
Standard Deviation 0.7571
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points
MCH, Follow-up, n=10, 8
|
-0.050 Picograms
Standard Deviation 1.1909
|
-0.250 Picograms
Standard Deviation 0.4598
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points
MCV, Week 8, n=176, 183
|
4.668 Femtoliter
Standard Deviation 62.5158
|
-0.090 Femtoliter
Standard Deviation 2.4759
|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points
MCV, Taper, n=13, 16
|
0.508 Femtoliter
Standard Deviation 2.2291
|
0.181 Femtoliter
Standard Deviation 2.1201
|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points
MCV, Follow-up, n=10, 8
|
0.320 Femtoliter
Standard Deviation 3.3565
|
0.287 Femtoliter
Standard Deviation 1.1205
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
RBC Count, Week 8, n=176, 183
|
-0.009 10^12 cells per liter
Standard Deviation 0.2711
|
-0.049 10^12 cells per liter
Standard Deviation 0.2563
|
|
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
RBC Count, Taper, n=13, 16
|
-0.088 10^12 cells per liter
Standard Deviation 0.1599
|
-0.007 10^12 cells per liter
Standard Deviation 0.2560
|
|
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
RBC Count, Follow-up, n=10, 8
|
-0.132 10^12 cells per liter
Standard Deviation 0.4018
|
0.036 10^12 cells per liter
Standard Deviation 0.1859
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Bupropion XL
n=266 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, high,Screening, n=265, 255
|
20 Participants
|
12 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, low,Screening, n=265, 255
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity,high, Week 8, n=171, 173
|
9 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity,low, Week 8, n=171, 173
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, high, Taper, n=18, 28
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, low, Taper, n=18, 28
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, high, Follow-up, n=7, 14
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine specific gravity, low, Follow-up, n=7, 14
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, high, Screening, n=265, 266
|
7 Participants
|
18 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, low, Screening, n=265, 266
|
37 Participants
|
28 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, high, Week 8, n=172, 178
|
5 Participants
|
9 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, low, Week 8, n=172, 178
|
23 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, high, Taper, n=18, 28
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, low, Taper, n=18, 28
|
2 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, high, Follow-up, n=7, 14
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Data Outside the Normal Range
Urine pH, low, Follow-up, n=7, 14
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP \<30 or \>170 millimeter of mercury (mmHg); DBP \<20 or \>110 mmHg and heart rate \<40 or \>120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Bupropion XL
n=260 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=253 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
SBP, high, Any visit post-Baseline
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
SBP, low,Any visit post-Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
DBP, high, Any visit post-Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
DBP, low, Any visit post-Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
HR, high, Any visit post-Baseline
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
HR, low, Any visit post-Baseline
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 10Population: Safety Population
ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval \<110 or \>220 millisecond (msec); QRS interval \<60 or \>120 msec and corrected QT (QTc) interval \>450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Bupropion XL
n=224 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=222 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
PR interval, high, Any visit post-randomization
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
PR interval, low,Any visit post-randomization
|
5 Participants
|
2 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
QRS interval, high, Any visit post-randomization
|
2 Participants
|
3 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
QRS interval, low, Any visit post-randomization
|
0 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
QTc interval, high, Any visit post-randomization
|
1 Participants
|
3 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
QTc interval, low, Any visit post-randomization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 8Population: Safety Population
CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Bupropion XL
n=173 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=179 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)
|
3.0 Scores on a scale
Standard Deviation 6.47
|
0.9 Scores on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Baseline and up to Taper visit (Week 9)Population: Safety Population
C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if "yes" answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a "yes" answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Bupropion XL
n=255 Participants
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=249 Participants
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation or Behavior
|
50 Participants
|
43 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
50 Participants
|
43 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
2 Participants
|
1 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Self-Injurious Behavior, no suicidal attempt
|
1 Participants
|
1 Participants
|
Adverse Events
Bupropion XL
Serious events: 10 serious events
Other events: 151 other events
Deaths: 1 deaths
Escitalopram
Serious events: 11 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion XL
n=266 participants at risk
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 participants at risk
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.5%
4/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Depression suicidal
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Lacrimal structure injury
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Conjunctivitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
Other adverse events
| Measure |
Bupropion XL
n=266 participants at risk
In a double-blind 8-week acute treatment phase, participants received 1 tablet of bupropion XL 150 milligram (mg) per day at dose level 1 (Week 0 to Week 1). At dose level 2 (Week 1 to Week 4), bupropion XL dose was increased to 300 mg per day (2 tablets of bupropion XL 150 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), bupropion XL dose was still maintained at 300 mg per day (2 tablets of bupropion XL 150 mg). To ensure study blind, the participants were dosed with placebo matching escitalopram at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
Escitalopram
n=268 participants at risk
In a double-blind 8-week acute treatment phase, participants received 1 capsule of escitalopram 10 mg per day at dose level 1 (Week 0 to Week 1). Escitalopram dose was maintained at 10 mg per day (1 capsule of Escitalopram 10 mg) for further 3 weeks to ensure that participants had achieved the clinical recommended dose. At dose level 3 (Week 4 to Week 8), the escitalopram dose could be increased to 20 mg per day (2 capsule of Escitalopram 10 mg). To ensure study blind, the participants were also dosed with placebo matching bupropion XL at each dose level. After treatment phase, participants entered in taper phase where dose in was down-titrated step by step to reduce the possible withdrawal symptoms. In taper phase, both dose level 2 and dose level 3 were down titrated to dose level 1 for 1 week before discontinuation.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.5%
28/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
18.7%
50/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
16/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
5.6%
15/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
14/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
3.4%
9/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
9/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
3.4%
9/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
2.2%
6/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
7/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.1%
3/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
5/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Regurgitation
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Eructation
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Dizziness
|
9.4%
25/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
8.6%
23/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Headache
|
7.5%
20/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
5.6%
15/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Somnolence
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
4.9%
13/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Tremor
|
3.0%
8/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Dysgeusia
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Head discomfort
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Poor quality sleep
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Anticholinergic syndrome
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Syncope
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Head titubation
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Nervous system disorders
Tension headache
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.6%
15/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
4.9%
13/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Influenza
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Pharyngitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Peritonsillitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Infections and infestations
Tonsillitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Asthenia
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.9%
5/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Fatigue
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.9%
5/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Thirst
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.5%
4/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Chest discomfort
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Pyrexia
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Chest pain
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Malaise
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Crying
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Discomfort
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Feeling hot
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Hunger
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Ill-defined disorder
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Inflammation
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Pain
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Insomnia
|
2.3%
6/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Anxiety
|
1.9%
5/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Agitation
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Dysphoria
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Initial insomnia
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Intentional self-injury
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Fear
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Irritability
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Middle insomnia
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
9/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.9%
5/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood glucose increased
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.9%
5/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
White blood cell count decreased
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Heart rate increased
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood pressure increased
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood triglycerides increased
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Weight increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Blood uric acid increased
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Electrocardiogram ST-T change
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Electrocardiogram high voltage
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Lipids abnormal
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Lipoprotein (a) increased
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Lymphocyte percentage increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Platelet count increased
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
11/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
5.6%
15/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Cardiac disorders
Palpitations
|
4.1%
11/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.9%
5/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Cardiac disorders
Tachycardia
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
1.1%
3/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
4/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Eye disorders
Vision blurred
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Eye disorders
Eye pain
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Eye disorders
Ocular discomfort
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Eye disorders
Photopsia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Vascular disorders
Hypertension
|
1.1%
3/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.75%
2/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.75%
2/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.37%
1/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.38%
1/266 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
0.00%
0/268 • Adverse events (AEs) were collected from the start of study treatment and until the end safety follow-up visit (up to Week 10). SAEs were recorded from the time the consent form is signed until the follow-up visit (up to Week 10).
SAEs and non-serious AEs were reported for the Safety Population which comprised of all participants who took at least one dose of the study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER