Trial Outcomes & Findings for Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (NCT NCT03613129)
NCT ID: NCT03613129
Last Updated: 2020-05-12
Results Overview
Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
Screen Failures
Patient enrolled, but screened-out before receiving treatment
|
D0.01
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
Pre-treatment Assessment
STARTED
|
3
|
3
|
7
|
2
|
2
|
|
Pre-treatment Assessment
COMPLETED
|
0
|
3
|
7
|
2
|
2
|
|
Pre-treatment Assessment
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Treatment
STARTED
|
0
|
3
|
7
|
2
|
2
|
|
Treatment
COMPLETED
|
0
|
3
|
7
|
2
|
2
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Post-treatment Assessment
STARTED
|
0
|
3
|
7
|
2
|
2
|
|
Post-treatment Assessment
COMPLETED
|
0
|
3
|
7
|
2
|
2
|
|
Post-treatment Assessment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Screen Failures
Patient enrolled, but screened-out before receiving treatment
|
D0.01
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
Pre-treatment Assessment
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
|
Pre-treatment Assessment
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
Baseline characteristics by cohort
| Measure |
D0.01
n=3 Participants
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 Participants
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 Participants
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 Participants
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 21.4 • n=4 Participants
|
43.7 years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, at diagnosis
|
33.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 24.7 • n=4 Participants
|
34.6 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
|
Disease onset
Gradual
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Disease onset
Sudden
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Disease triggers
Infection
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Disease triggers
Toxins
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Disease triggers
Over-exertion
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Disease triggers
Emotion
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)
Outcome measures
| Measure |
Intent-to-treat
n=14 Participants
All patients receiving test drug
|
D0.01
n=3 Participants
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 Participants
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 Participants
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 Participants
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
Total Daily Symptom Score (TDSS)
Pre-treatment TDSS
|
29.5 units on a scale
Standard Deviation 9.4
|
28.7 units on a scale
Standard Deviation 12.2
|
29.2 units on a scale
Standard Deviation 11.4
|
31.3 units on a scale
Standard Deviation 1.3
|
30.1 units on a scale
Standard Deviation 8.0
|
|
Total Daily Symptom Score (TDSS)
Post-treatment TDSS
|
25.3 units on a scale
Standard Deviation 9.6
|
25.5 units on a scale
Standard Deviation 10.5
|
21.7 units on a scale
Standard Deviation 10.3
|
29.5 units on a scale
Standard Deviation 3.5
|
33.0 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)
Outcome measures
| Measure |
Intent-to-treat
n=14 Participants
All patients receiving test drug
|
D0.01
n=3 Participants
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 Participants
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 Participants
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 Participants
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
SF-36, PCS
Pre-treatment PCS
|
27.9 units on a scale
Standard Deviation 4.0
|
25.9 units on a scale
Standard Deviation 6.9
|
24.6 units on a scale
Standard Deviation 3.7
|
27.6 units on a scale
Standard Deviation 1.4
|
30.6 units on a scale
Standard Deviation 1.4
|
|
SF-36, PCS
Post-treatment PCS
|
31.5 units on a scale
Standard Deviation 5.8
|
29.1 units on a scale
Standard Deviation 6.0
|
30.7 units on a scale
Standard Deviation 5.3
|
27.0 units on a scale
Standard Deviation 1.4
|
26.8 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)
Outcome measures
| Measure |
Intent-to-treat
n=14 Participants
All patients receiving test drug
|
D0.01
n=3 Participants
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 Participants
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 Participants
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 Participants
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
SF-36, MCS
Pre-treatment MCS
|
34.0 units on a scale
Standard Deviation 3.6
|
36.3 units on a scale
Standard Deviation 3.2
|
28.9 units on a scale
Standard Deviation 3.9
|
32.1 units on a scale
Standard Deviation 3.2
|
35.8 units on a scale
Standard Deviation 2.6
|
|
SF-36, MCS
Post-treatment MCS
|
34.8 units on a scale
Standard Deviation 6.3
|
38.5 units on a scale
Standard Deviation 9.1
|
29.9 units on a scale
Standard Deviation 6.4
|
34.9 units on a scale
Standard Deviation 5.6
|
31.5 units on a scale
Standard Deviation 2.1
|
Adverse Events
Intent-to-treat
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
D0.01
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
D0.03
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
D0.06
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
D0.20
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intent-to-treat
n=14 participants at risk
All patients receiving test drug
|
D0.01
n=3 participants at risk
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 participants at risk
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 participants at risk
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 participants at risk
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
Other adverse events
| Measure |
Intent-to-treat
n=14 participants at risk
All patients receiving test drug
|
D0.01
n=3 participants at risk
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.03
n=7 participants at risk
Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.06
n=2 participants at risk
Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days
|
D0.20
n=2 participants at risk
Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety State
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Blood and lymphatic system disorders
Swollen lymph nodes
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Cardiac disorders
Palpitations
|
14.3%
2/14 • Number of events 5 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 3 • At least 10 weeks
|
50.0%
1/2 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Cardiac disorders
Premature ventricular contraction
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
100.0%
2/2 • Number of events 2 • At least 10 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Eye disorders
Conjunctivitis
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Eye disorders
Hyperemic eyes
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 2 • At least 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 4 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
42.9%
3/7 • Number of events 4 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Gastrointestinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Asthenia
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Body aches
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Body temperature abnormalities
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Fatigue
|
35.7%
5/14 • Number of events 10 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
42.9%
3/7 • Number of events 5 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
100.0%
2/2 • Number of events 5 • At least 10 weeks
|
|
General disorders
Influenza like illness
|
21.4%
3/14 • Number of events 3 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
General disorders
Malaise
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Pain & discomfort
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Chills
|
21.4%
3/14 • Number of events 6 • At least 10 weeks
|
33.3%
1/3 • Number of events 4 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Agitation
|
14.3%
2/14 • Number of events 3 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Forgetfulness
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Headache
|
78.6%
11/14 • Number of events 18 • At least 10 weeks
|
100.0%
3/3 • Number of events 6 • At least 10 weeks
|
71.4%
5/7 • Number of events 8 • At least 10 weeks
|
100.0%
2/2 • Number of events 3 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Nervous system disorders
Restlessness
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Tremor
|
14.3%
2/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Wired
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Dysequilibrium
|
14.3%
2/14 • Number of events 2 • At least 10 weeks
|
66.7%
2/3 • Number of events 2 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Paresthesia
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Nervous system disorders
Dizziness
|
28.6%
4/14 • Number of events 4 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
28.6%
2/7 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Psychiatric disorders
Cognitive disturbance
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
33.3%
1/3 • Number of events 2 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Psychiatric disorders
Emotional lability
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Psychiatric disorders
Sleep disorder disturbance
|
42.9%
6/14 • Number of events 7 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
57.1%
4/7 • Number of events 5 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
21.4%
3/14 • Number of events 3 • At least 10 weeks
|
66.7%
2/3 • Number of events 2 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
7.1%
1/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
28.6%
4/14 • Number of events 4 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
57.1%
4/7 • Number of events 4 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Vascular disorders
Facial flushing
|
42.9%
6/14 • Number of events 10 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
42.9%
3/7 • Number of events 7 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
100.0%
2/2 • Number of events 2 • At least 10 weeks
|
|
Vascular disorders
Flushing
|
92.9%
13/14 • Number of events 27 • At least 10 weeks
|
100.0%
3/3 • Number of events 6 • At least 10 weeks
|
85.7%
6/7 • Number of events 14 • At least 10 weeks
|
100.0%
2/2 • Number of events 5 • At least 10 weeks
|
100.0%
2/2 • Number of events 2 • At least 10 weeks
|
|
Vascular disorders
Hot flushes
|
21.4%
3/14 • Number of events 3 • At least 10 weeks
|
33.3%
1/3 • Number of events 1 • At least 10 weeks
|
28.6%
2/7 • Number of events 2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • Number of events 2 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
14.3%
1/7 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
|
Vascular disorders
Pallor
|
7.1%
1/14 • Number of events 1 • At least 10 weeks
|
0.00%
0/3 • At least 10 weeks
|
0.00%
0/7 • At least 10 weeks
|
50.0%
1/2 • Number of events 1 • At least 10 weeks
|
0.00%
0/2 • At least 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60