Trial Outcomes & Findings for Phase II Study of BNC210 in PTSD (NCT NCT02933606)
NCT ID: NCT02933606
Last Updated: 2023-02-27
Results Overview
Investigator-rated PTSD symptom severity. The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
193 participants
Primary outcome timeframe
12 weeks.
Results posted on
2023-02-27
Participant Flow
193 participants were enrolled into the study and randomized to one of the 4 treatment arms. However, 1 participant withdrew from the study prior to beginning treatment with study IP and hence is not included in the overall number of 192 participants who received study IP and for which post-baseline assessments were performed.
Participant milestones
| Measure |
BNC210 600 mg b.i.d.
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
47
|
49
|
|
Overall Study
COMPLETED
|
33
|
39
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
14
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of BNC210 in PTSD
Baseline characteristics by cohort
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
41 participants
n=5 Participants
|
38 participants
n=4 Participants
|
161 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
11 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks.Investigator-rated PTSD symptom severity. The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
|
15.26 score on a scale
Interval 11.2 to 19.3
|
16.62 score on a scale
Interval 12.3 to 20.9
|
19.76 score on a scale
Interval 15.5 to 24.0
|
14.57 score on a scale
Interval 9.8 to 19.4
|
SECONDARY outcome
Timeframe: 12 weeks.Self-reported PTSD symptom severity. The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
|
25.02 score on a scale
Interval 19.1 to 31.0
|
20.99 score on a scale
Interval 15.3 to 26.7
|
29.97 score on a scale
Interval 23.5 to 36.4
|
24.65 score on a scale
Interval 17.8 to 31.5
|
SECONDARY outcome
Timeframe: 12 weeks.Depression severity. The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Montgomery- Åsberg Depression Rating Scale (MADRS).
|
9.48 score on a scale
Interval 6.7 to 12.3
|
10.25 score on a scale
Interval 7.7 to 12.8
|
12.16 score on a scale
Interval 9.4 to 14.9
|
8.94 score on a scale
Interval 6.1 to 11.8
|
SECONDARY outcome
Timeframe: 12 weeksAnxiety severity. The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A).
|
9.03 score on a scale
Interval 6.6 to 11.5
|
9.94 score on a scale
Interval 7.6 to 12.3
|
10.55 score on a scale
Interval 8.1 to 13.0
|
7.94 score on a scale
Interval 5.3 to 10.6
|
SECONDARY outcome
Timeframe: 12 weeksClinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=39 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=30 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Normal, not at all ill
|
10 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Borderline mentally ill
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Mildly ill
|
8 Participants
|
16 Participants
|
8 Participants
|
5 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Moderately ill
|
9 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Markedly ill
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Severely ill
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Clinical Global Impressions - Severity Scale (CGI-S).
Among the most extremely ill patients
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksClinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=39 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=30 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Clinical Global Impressions - Improvement Scale (CGI-I).
Very Much Improved/Much Improved
|
22 Participants
|
23 Participants
|
15 Participants
|
19 Participants
|
|
Clinical Global Impressions - Improvement Scale (CGI-I).
Other
|
11 Participants
|
16 Participants
|
18 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 weeks.Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=39 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=30 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Patient Global Impressions - Severity Scale (PGI-S).
Normal
|
11 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
|
Patient Global Impressions - Severity Scale (PGI-S).
Mild
|
8 Participants
|
21 Participants
|
14 Participants
|
13 Participants
|
|
Patient Global Impressions - Severity Scale (PGI-S).
Moderate
|
12 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
|
Patient Global Impressions - Severity Scale (PGI-S).
Severe
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeks.Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=39 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=33 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=30 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Patient Global Impression - Improvement Scale (PGI-I).
Very Much/Much Improved
|
17 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Patient Global Impression - Improvement Scale (PGI-I).
Other
|
16 Participants
|
19 Participants
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 weeks.Quality of Life. The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Assessment of Quality of Life (AQoL-8D).
|
77.95 score on a scale
Interval 71.4 to 84.5
|
76.79 score on a scale
Interval 70.3 to 83.3
|
85.47 score on a scale
Interval 78.0 to 93.0
|
81.05 score on a scale
Interval 73.3 to 88.9
|
SECONDARY outcome
Timeframe: 12 weeks.Social functioning. The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Social Functioning: Sheehan Disability Scale (SDS).
|
8.84 score on a scale
Interval 6.2 to 11.5
|
6.66 score on a scale
Interval 4.0 to 9.3
|
10.32 score on a scale
Interval 7.5 to 13.1
|
8.47 score on a scale
Interval 5.3 to 11.7
|
SECONDARY outcome
Timeframe: 12 weeks.Sleep quality and duration. The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
|
8.80 score on a scale
Interval 7.5 to 10.1
|
8.83 score on a scale
Interval 7.6 to 10.1
|
9.15 score on a scale
Interval 7.7 to 10.6
|
8.00 score on a scale
Interval 6.4 to 9.6
|
SECONDARY outcome
Timeframe: 12 WeeksThe CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better) A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean
Outcome measures
| Measure |
BNC210 600 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 Participants
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 Participants
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 Participants
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
|
0.06 Composite Z score
Interval -0.1 to 0.2
|
0.12 Composite Z score
Interval 0.0 to 0.2
|
0.18 Composite Z score
Interval 0.1 to 0.3
|
0.02 Composite Z score
Interval -0.1 to 0.2
|
Adverse Events
BNC210 600 mg b.i.d.
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
BNC210 300 mg b.i.d.
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
BNC210 150 mg b.i.d.
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo b.i.d.
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BNC210 600 mg b.i.d.
n=48 participants at risk
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 participants at risk
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 participants at risk
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 participants at risk
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/48 • 15 Weeks
|
0.00%
0/48 • 15 Weeks
|
0.00%
0/47 • 15 Weeks
|
2.0%
1/49 • Number of events 1 • 15 Weeks
|
|
Investigations
Elevated Liver Function Tests
|
0.00%
0/48 • 15 Weeks
|
2.1%
1/48 • Number of events 1 • 15 Weeks
|
0.00%
0/47 • 15 Weeks
|
0.00%
0/49 • 15 Weeks
|
Other adverse events
| Measure |
BNC210 600 mg b.i.d.
n=48 participants at risk
Suspension administered orally for 12 weeks.
|
BNC210 300 mg b.i.d.
n=48 participants at risk
Suspension administered orally for 12 weeks.
|
BNC210 150 mg b.i.d.
n=47 participants at risk
Suspension administered orally for 12 weeks.
|
Placebo b.i.d.
n=49 participants at risk
Suspension administered orally for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
4/48 • Number of events 5 • 15 Weeks
|
12.5%
6/48 • Number of events 8 • 15 Weeks
|
8.5%
4/47 • Number of events 4 • 15 Weeks
|
12.2%
6/49 • Number of events 6 • 15 Weeks
|
|
Gastrointestinal disorders
Nausea
|
8.3%
4/48 • Number of events 5 • 15 Weeks
|
8.3%
4/48 • Number of events 5 • 15 Weeks
|
4.3%
2/47 • Number of events 3 • 15 Weeks
|
12.2%
6/49 • Number of events 9 • 15 Weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
6.2%
3/48 • Number of events 3 • 15 Weeks
|
0.00%
0/48 • 15 Weeks
|
6.4%
3/47 • Number of events 3 • 15 Weeks
|
6.1%
3/49 • Number of events 3 • 15 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48 • 15 Weeks
|
2.1%
1/48 • Number of events 1 • 15 Weeks
|
4.3%
2/47 • Number of events 3 • 15 Weeks
|
6.1%
3/49 • Number of events 3 • 15 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
1/48 • Number of events 1 • 15 Weeks
|
0.00%
0/48 • 15 Weeks
|
0.00%
0/47 • 15 Weeks
|
6.1%
3/49 • Number of events 4 • 15 Weeks
|
|
Nervous system disorders
Headache
|
6.2%
3/48 • Number of events 9 • 15 Weeks
|
20.8%
10/48 • Number of events 15 • 15 Weeks
|
8.5%
4/47 • Number of events 4 • 15 Weeks
|
24.5%
12/49 • Number of events 17 • 15 Weeks
|
|
Nervous system disorders
Dizziness
|
4.2%
2/48 • Number of events 2 • 15 Weeks
|
6.2%
3/48 • Number of events 7 • 15 Weeks
|
2.1%
1/47 • Number of events 1 • 15 Weeks
|
8.2%
4/49 • Number of events 4 • 15 Weeks
|
|
Nervous system disorders
Somnolence
|
6.2%
3/48 • Number of events 3 • 15 Weeks
|
6.2%
3/48 • Number of events 3 • 15 Weeks
|
4.3%
2/47 • Number of events 2 • 15 Weeks
|
2.0%
1/49 • Number of events 1 • 15 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
4/48 • Number of events 4 • 15 Weeks
|
6.2%
3/48 • Number of events 3 • 15 Weeks
|
12.8%
6/47 • Number of events 6 • 15 Weeks
|
4.1%
2/49 • Number of events 2 • 15 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
4/48 • Number of events 4 • 15 Weeks
|
4.2%
2/48 • Number of events 2 • 15 Weeks
|
2.1%
1/47 • Number of events 1 • 15 Weeks
|
2.0%
1/49 • Number of events 1 • 15 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/48 • 15 Weeks
|
4.2%
2/48 • Number of events 2 • 15 Weeks
|
2.1%
1/47 • Number of events 1 • 15 Weeks
|
6.1%
3/49 • Number of events 5 • 15 Weeks
|
|
Infections and infestations
Viral Infection
|
2.1%
1/48 • Number of events 1 • 15 Weeks
|
6.2%
3/48 • Number of events 3 • 15 Weeks
|
4.3%
2/47 • Number of events 2 • 15 Weeks
|
0.00%
0/49 • 15 Weeks
|
|
General disorders
Fatigue
|
4.2%
2/48 • Number of events 2 • 15 Weeks
|
10.4%
5/48 • Number of events 5 • 15 Weeks
|
4.3%
2/47 • Number of events 2 • 15 Weeks
|
2.0%
1/49 • Number of events 1 • 15 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER