Trial Outcomes & Findings for Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (NCT NCT01970501)
NCT ID: NCT01970501
Last Updated: 2022-09-26
Results Overview
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
267 participants
Primary outcome timeframe
end of treatment week 24
Results posted on
2022-09-26
Participant Flow
The study recruitment period began in Feb 2014 and the first participant screen was Apr 2014 and first randomization was Jun 2014. Recruitment continued through Jul 2017. Recruitment periods by country as follows: Canada: Mar 15 - Jul 17 Hungary: Sep 16 - Jun 17 Netherlands: May 1 - Jul 17 Poland: Jan 17 - Jul 17 Serbia: May 17 - Jun 17 United States: Feb 14 - Jul 17
During the drug lead in period, participants were uptitrated to target doses of each drug. Bucindolol target dose was 50 mg bid (subjects \< 75 kg) or 100 mg bid (subjects \>= 75 kg) or maximum tolerated dose. Metoprolol succinate target dose was 200 mg once daily or the maximum tolerated dose. Within each treatment arm, participants were combined for analysis.
Participant milestones
| Measure |
Bucindolol Hydrochloride
Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. The starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the target dose or to the maximum tolerated dose. The bucindolol target dose varied based on the patient's weight on the day of randomization: patients \< 75 kg receiving a target dose of 50 mg BID (100 mg daily) and patients \> 75 kg receiving a target dose of 100 mg BID (200 mg daily).
Capsules were available for titration in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
|
Metoprolol Succinate
metoprolol succinate (Toprol-XL)
Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. The starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the target dose or to the maximum tolerated dose. The bucindolol target dose varied based on the patient's weight on the day of randomization: patients \< 75 kg receiving a target dose of 50 mg BID (100 mg daily) and patients \> 75 kg receiving a target dose of 100 mg BID (200 mg daily).
Capsules were available for titration in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
133
|
|
Overall Study
Randomization (Visit 2)
|
134
|
133
|
|
Overall Study
Initial Dose Level 1
|
35
|
45
|
|
Overall Study
Initial Dose Level 2
|
45
|
38
|
|
Overall Study
Initial Dose Level 3
|
51
|
45
|
|
Overall Study
Initial Dose Level 4
|
3
|
5
|
|
Overall Study
Drug Lead-in Period
|
134
|
133
|
|
Overall Study
Attained Target Dose
|
112
|
96
|
|
Overall Study
24-Week Follow Up Period
|
132
|
126
|
|
Overall Study
Treatment Extension Period
|
77
|
64
|
|
Overall Study
COMPLETED
|
107
|
105
|
|
Overall Study
NOT COMPLETED
|
27
|
28
|
Reasons for withdrawal
| Measure |
Bucindolol Hydrochloride
Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. The starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the target dose or to the maximum tolerated dose. The bucindolol target dose varied based on the patient's weight on the day of randomization: patients \< 75 kg receiving a target dose of 50 mg BID (100 mg daily) and patients \> 75 kg receiving a target dose of 100 mg BID (200 mg daily).
Capsules were available for titration in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
|
Metoprolol Succinate
metoprolol succinate (Toprol-XL)
Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. The starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the target dose or to the maximum tolerated dose. The bucindolol target dose varied based on the patient's weight on the day of randomization: patients \< 75 kg receiving a target dose of 50 mg BID (100 mg daily) and patients \> 75 kg receiving a target dose of 100 mg BID (200 mg daily).
Capsules were available for titration in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
|
|---|---|---|
|
Overall Study
Discontinuation of study by sponsor
|
16
|
14
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Baseline characteristics by cohort
| Measure |
Bucindolol Hydrochloride
n=134 Participants
bucindolol hydrochloride (bucindolol)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=133 Participants
metoprolol succinate (Toprol-XL)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
158 Participants
n=27 Participants
|
|
Age, Continuous
|
65 years
n=93 Participants
|
65 years
n=4 Participants
|
65 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
219 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=93 Participants
|
128 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
32 participants
n=93 Participants
|
27 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
18 participants
n=93 Participants
|
15 participants
n=4 Participants
|
33 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
67 participants
n=4 Participants
|
127 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
13 participants
n=93 Participants
|
10 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Serbia
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
New York Heart Association (NYHA) Functional Class at screen
NYHA I
|
40 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
New York Heart Association (NYHA) Functional Class at screen
NYHA II
|
80 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
152 Participants
n=27 Participants
|
|
New York Heart Association (NYHA) Functional Class at screen
NYHA III
|
14 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
New York Heart Association (NYHA) Functional Class at screen
NYHA IV
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ischemic Heart Failure
|
42 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Non-Ischemic Heart Failure
|
92 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
Average Left Ventricular Ejection Fraction (LVEF) (%)
|
36 %
n=93 Participants
|
36 %
n=4 Participants
|
36 %
n=27 Participants
|
|
Rhythm at randomization
Atrial Fibrillation
|
66 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Rhythm at randomization
Sinus Rhythm
|
68 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
132 Participants
n=27 Participants
|
|
Type of Atrial Fibrillation
Paroxysmal
|
66 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
Type of Atrial Fibrillation
Persistent
|
68 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: end of treatment week 24Population: Time to first event of symptomatic atrial fibrillation/atrial flutter (AF/AFL) or all cause mortality (ACM) during the 24-week Follow-up Period after establishment of stable sinus rhythm (SR) on study drug \[end of treatment week 24\]. Results from participants were combined for analysis within each treatment arm. Mean time to event (days) is presented for the participants experiencing an event.
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.
Outcome measures
| Measure |
Bucindolol Hydrochloride
n=69 Participants
bucindolol hydrochloride (bucindolol)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=67 Participants
metoprolol succinate (Toprol-XL)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Time to First Event of Symptomatic Atrial Fibrillation/Atrial Flutter (AF/AFL) or All Cause Mortality (ACM) During the 24-week Follow-up Period After Establishment of Stable Sinus Rhythm (SR) on Study Drug [End of Treatment Week 24].
|
35.9 days
Interval 9.0 to 53.0
|
33.2 days
Interval 6.0 to 47.0
|
SECONDARY outcome
Timeframe: end of treatment week 24Population: Time to first event of symptomatic or asymptomatic atrial fibrillation/atrial flutter (AF/AFL) or all cause mortality (ACM) during the 24-week Follow-up Period after establishment of stable sinus rhythm (SR) on study drug \[end of treatment week 24\]. Mean time to event (days) is presented for the participants experiencing an event.
Number of days on study medication before participant experienced symptomatic or asymptomatic atrial fibrillation, atrial flutter, or all-cause mortality during the 24 week follow up period.
Outcome measures
| Measure |
Bucindolol Hydrochloride
n=73 Participants
bucindolol hydrochloride (bucindolol)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=70 Participants
metoprolol succinate (Toprol-XL)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Time to First Event of Symptomatic or Asymptomatic AF/AFL or ACM During the 24-week Follow-up Period After Establishment of Stable SR on Study Drug [End of Treatment Week 24]
|
37.86 days
Interval 9.0 to 53.0
|
31.06 days
Interval 6.0 to 40.5
|
SECONDARY outcome
Timeframe: end of treatment week 24Number of patients with adequate ventricular rate control following the start of medication during the 24-week Follow-up Period
Outcome measures
| Measure |
Bucindolol Hydrochloride
n=134 Participants
bucindolol hydrochloride (bucindolol)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=133 Participants
metoprolol succinate (Toprol-XL)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Number of Patients With Adequate Ventricular Rate Control During the 24-week Follow-up Period
|
84 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: A summary of all-cause and HF hospitalizations by treatment group over the 24-week study period
Total number of hospitalization days per patient (all-cause) following the start of study medication during the Total Study Period (24 weeks). Hospitalization was defined by a hospital admission (note that same day admit and discharge equates to 0 days duration), ER visits were not counted as events.
Outcome measures
| Measure |
Bucindolol Hydrochloride
n=123 Unique Inpatient Hospitalizations
bucindolol hydrochloride (bucindolol)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=87 Unique Inpatient Hospitalizations
metoprolol succinate (Toprol-XL)
Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Total Number of Hospitalization Days Per Patient (All-cause) During the Total Study Period (24 Weeks)
|
2 days
Interval 1.0 to 4.0
|
2 days
Interval 1.0 to 4.0
|
Adverse Events
Bucindolol Hydrochloride
Serious events: 33 serious events
Other events: 100 other events
Deaths: 3 deaths
Metoprolol Succinate
Serious events: 26 serious events
Other events: 95 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Bucindolol Hydrochloride
n=134 participants at risk
bucindolol hydrochloride (bucindolol)
Capsules were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=133 participants at risk
metoprolol succinate (Toprol-XL)
Capsules were available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Angina pectoris
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiac tamponade
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Sepsis
|
2.2%
3/134 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Septic shock
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
3/134 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
5.3%
7/133 • Number of events 7 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiac failure
|
3.0%
4/134 • Number of events 4 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
2.3%
3/133 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiogenic shock
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiomyopathy
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Pneumonia
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Bronchitis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Diverticulitis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Pneumonia bacterial
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Sinusitis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Staphylcoccal bacteraemia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic spasm
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Hypotension
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
1.5%
2/133 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Hypertension
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
3/134 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
1.5%
2/133 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Urinary retention
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Haemorrhagic necrotic pancreatitis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Ileus
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Non-cardiac chest pain
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Sudden death
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Syncope
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Product Issues
Lead dislodgement
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Product Issues
Device lead damage
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.75%
1/133 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Cellulitis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Vascular stent restenosis
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/133 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
Bucindolol Hydrochloride
n=134 participants at risk
bucindolol hydrochloride (bucindolol)
Capsules were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
bucindolol hydrochloride
|
Metoprolol Succinate
n=133 participants at risk
metoprolol succinate (Toprol-XL)
Capsules were available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
metoprolol succinate
Placebo oral capsule
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
8/134 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
7.5%
10/133 • Number of events 10 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Bradycardia
|
3.7%
5/134 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
6.8%
9/133 • Number of events 9 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Cardiac failure
|
5.2%
7/134 • Number of events 7 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
3.8%
5/133 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/134 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
6.0%
8/133 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
8/134 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
8/134 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
1.5%
2/133 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
7/134 • Number of events 7 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
3.8%
5/133 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Dizziness
|
3.7%
5/134 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Vascular disorders
Hypotension
|
9.7%
13/134 • Number of events 13 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
7.5%
10/133 • Number of events 10 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Fatigue
|
4.5%
6/134 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
5.3%
7/133 • Number of events 7 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
3/134 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
5.3%
7/133 • Number of events 7 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition
|
14.2%
19/134 • Number of events 19 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
12.0%
16/133 • Number of events 16 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.75%
1/134 • Number of events 1 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Investigations
Investigations
|
12.7%
17/134 • Number of events 17 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
7.5%
10/133 • Number of events 10 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
6/134 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Psychiatric disorders
Psychiatric disorder
|
1.5%
2/134 • Number of events 2 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
9.0%
12/133 • Number of events 12 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Eye disorders
Eye disorder
|
6.0%
8/134 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
3.0%
4/133 • Number of events 4 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
6/134 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
5/134 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.5%
6/133 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Headache
|
4.5%
6/134 • Number of events 6 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
3.8%
5/133 • Number of events 5 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
9.7%
13/134 • Number of events 13 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
6.0%
8/133 • Number of events 8 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
2.2%
3/134 • Number of events 3 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
6.8%
9/133 • Number of events 9 • Results were collected from first dose of study drug to the later of 30 days after last dose or last study evaluation (final visit) for each participant ("total study period"; e.g., up to day 1184). Adverse Events were not collected per specific doses, rather participants were combined for analysis within each treatment arm. All AEs reported during the course of the study were coded to a body system and preferred term using the Medical Dictionary for Regulatory Activities (medDRA) version 6.1.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place