Trial Outcomes & Findings for Study of Rifampicin in Multiple System Atrophy (NCT NCT01287221)
NCT ID: NCT01287221
Last Updated: 2014-03-28
Results Overview
UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction). Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
baseline, 12 months
Results posted on
2014-03-28
Participant Flow
Subjects were enrolled from 10 specialized tertiary centers in the United States from April 2011 through April 2012.
Participant milestones
| Measure |
Rifampicin
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Completed 3 Months Follow-up
|
49
|
50
|
|
Overall Study
Completed 6 Months Follow-up
|
47
|
43
|
|
Overall Study
Completed 9 Months Follow-up
|
42
|
40
|
|
Overall Study
Completed 12 Months Follow-up
|
40
|
39
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Rifampicin
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Overall Study
Lack of Perceived Benefit
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Rifampicin in Multiple System Atrophy
Baseline characteristics by cohort
| Measure |
Rifampicin
n=50 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=50 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Multiple System Atrophy (MSA) Type
Parkinsonian (MSA-P)
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Multiple System Atrophy (MSA) Type
Cerebellar (MSA-C)
|
31 participants
n=5 Participants
|
28 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Certainty of Multiple System Atrophy (MSA) Diagnosis
Probable
|
31 participants
n=5 Participants
|
34 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Certainty of Multiple System Atrophy (MSA) Diagnosis
Possible
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit.
UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction). Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months.
Outcome measures
| Measure |
Rifampicin
n=49 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=50 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11)
|
0.5 units on a scale per month
Standard Deviation 0.7
|
0.5 units on a scale per month
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).
Outcome measures
| Measure |
Rifampicin
n=39 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=39 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11)
|
6.2 units on a scale
Standard Deviation 5.6
|
5.6 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction).
Outcome measures
| Measure |
Rifampicin
n=36 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=36 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Change From Baseline to 12 Months in UMSARS Part II
|
7.0 units on a scale
Standard Deviation 6.3
|
5.4 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).
Outcome measures
| Measure |
Rifampicin
n=36 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=36 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II)
|
12.9 units on a scale
Standard Deviation 10.6
|
10.8 units on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction). Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months.
Outcome measures
| Measure |
Rifampicin
n=45 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=43 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate
|
1.1 units on a scale per month
Standard Deviation 1.0
|
1.2 units on a scale per month
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS\_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from "much worse" to "no such symptoms." Scores could range from 0 (no such symptoms) to 85 (much worse).
Outcome measures
| Measure |
Rifampicin
n=39 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=38 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Change From Baseline to 12 Months in the COMPASS-Select Scale
|
6.9 units on a scale
Standard Deviation 16.5
|
4.6 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.
The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from "much worse" to "no such symptoms." The score could range from 0 (no such symptoms) to 94 (much worse).
Outcome measures
| Measure |
Rifampicin
n=39 Participants
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=38 Participants
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Change in the COMPASS-Select-Change Scale From Baseline to 12 Months
|
41.4 units on a scale
Standard Deviation 33.8
|
32.1 units on a scale
Standard Deviation 35.7
|
Adverse Events
Rifampicin
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifampicin
n=50 participants at risk
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=50 participants at risk
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint Function
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Infections and infestations
Infection with unknown ANC
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - other
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Vessel injury - artery
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Death not associated with CTCAE Term
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Psychiatric disorders
Mood Alteration
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Cardiac general - other
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Renal/genitourinary - other
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Hepatobiliary disorders
Liver Dysfunction/failure
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
Neurology - other
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
Vomiting - aspirated/stroke
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
Other adverse events
| Measure |
Rifampicin
n=50 participants at risk
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
|
Placebo
n=50 participants at risk
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
|
|---|---|---|
|
General disorders
Speech impairment
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Cardiac disorders
Prolonged QTc Interval
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Immune system disorders
Leukocytes
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
6/50 • Number of events 6 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Immune system disorders
Neutrophils/granulocytes
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Infections and infestations
Wound complication, non-infectious
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
6.0%
3/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
16.0%
8/50 • Number of events 12 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Pain
|
12.0%
6/50 • Number of events 6 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Fatigue
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
Petechiae/purpura
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Blood and lymphatic system disorders
Edema: limb
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Infections and infestations
Infection with unknown
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
1/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Endocrine disorders
Glucose, serum-low
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Constitutional Symptoms - other
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Creatinine
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
Neurology - other
|
8.0%
4/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
10.0%
5/50 • Number of events 5 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Cavity/paranasal sinus reactions
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Cystitis
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
10.0%
5/50 • Number of events 5 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
8.0%
4/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - other
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
6.0%
3/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Taste Alteration (dysgeusia)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
Neuropathy: sensory
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Eye disorders
Vision - photophobia
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Dizziness
|
6.0%
3/50 • Number of events 4 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Renal and urinary disorders
Urine color change
|
10.0%
5/50 • Number of events 5 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
12.0%
6/50 • Number of events 6 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
Hemorrhage/bleeding - other
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Metabolic/Laboratory - other
|
8.0%
4/50 • Number of events 5 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
8.0%
4/50 • Number of events 8 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Syncope (fainting)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Endocrine disorders
Endocrine - other
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Allergic reaction/hypersensitivity
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
Blood/Bone marrow - other
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Endocrine disorders
Glucose, serum-high
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Endocrine disorders
Hepatobiliary/Pancreas - other
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Joint Function
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Rigors/chills
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - other
|
4.0%
2/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Skin and subcutaneous tissue disorders
Sweating (diasporesis)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Psychiatric disorders
Mood alteration
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Weight loss
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Eye disorders
Vision - blurred vision
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Bone: spine - scoliosis
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Somnolence/depressed level of consciousness
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - other
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
6.0%
3/50 • Number of events 3 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
1/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Vascular disorders
International Normalized Ratio (INR) of prothrombin time
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Hepatobiliary disorders
ALT, serum glutamic pyruvic transaminase (SGPT)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
4.0%
2/50 • Number of events 6 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Hepatobiliary disorders
AST, serum glutamic oxaloacetic transaminase (SGOT)
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
General disorders
Dry mouth/salivary gland (xerostomia)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Psychiatric disorders
Memory Impairment
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
4.0%
2/50 • Number of events 2 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.0%
1/50 • Number of events 1 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
0.00%
0/50 • Adverse events were to be recorded from the time a participant signed the informed consent form and throughout the 12 months of the study, even if they prematurely discontinued the study drug.
The attribution of serious adverse events was determined by the Medical Review Officer, whereas the attribution of non-serious adverse events was determined by the reporter.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place