Trial Outcomes & Findings for Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) (NCT NCT04056195)
NCT ID: NCT04056195
Last Updated: 2024-07-10
Results Overview
Platelet count \>= 30,000/µL and doubling the baseline (average of 2 previous counts)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to week 12
Results posted on
2024-07-10
Participant Flow
A total of 61 subjects were randomly assigned to receive the study drugs, of whom 60 subjects were included in the ITT set and the safety set each. Note: 1 subject was randomly assigned to the 400 mg BID group but did not receive any dose of study drug as the subject was withdrawn due to noncompliance with the protocol.
Participant milestones
| Measure |
SKI-O-703 200 mg BID
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
12
|
|
Overall Study
COMPLETED
|
24
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
SKI-O-703 200 mg BID
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
Baseline Characteristics
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Baseline characteristics by cohort
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 14.98 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 22.24 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 16.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race, n(%) · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race, n(%) · Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race, n(%) · White
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, n(%) · Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, n(%) · Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Number of previous lines of therapy category, n (%)
0-2
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Number of previous lines of therapy category, n (%)
≥3
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Response to previous treatment, n (%)
Non-responder
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Response to previous treatment, n (%)
Relapsed
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Previous splenectomy, n (%)
Yes
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Previous splenectomy, n (%)
No
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Baseline platelet count
|
10.6 cells*10^9/L
STANDARD_DEVIATION 6.69 • n=5 Participants
|
11.5 cells*10^9/L
STANDARD_DEVIATION 8.28 • n=7 Participants
|
9.6 cells*10^9/L
STANDARD_DEVIATION 7.22 • n=5 Participants
|
10.7 cells*10^9/L
STANDARD_DEVIATION 7.32 • n=4 Participants
|
|
Baseline platelet count category, n (%)
<15,000/μL
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Baseline platelet count category, n (%)
15,000/μL-30,000/μL
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
TPO-receptor agonist use, n (%)
Yes
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
TPO-receptor agonist use, n (%)
No
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to week 12Population: ITT Set
Platelet count \>= 30,000/µL and doubling the baseline (average of 2 previous counts)
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Platelet Response
|
12 Participants
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to week 16The number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Discontinuation each.
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
AEs leading to Discontinuation
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
Adverse Events (AEs)
|
15 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
Serious Adverse Events (SAEs)
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to week 16Vital sign measurements considered to be clinically significant in the medical and scientific judgement of the investigator are recorded as AEs.
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to week 1612-lead electrocardiogram (ECG) abnormalities that were recorded as adverse events
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to week 16Physical examination abnormalities that were recorded as adverse events
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities
|
4 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to week 16Population: Safety set defined as all subjects who received at least 1 dose of study drug (SKI-O-703 or placebo).
Qualtiy of Life as measured by the Short Form Questionnaire (SF-36) consists of eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Scale scores range 0-100 scores (theoritically), with higher scores indicating better health. Each health domain score contributes to the Physical Component Summary(PCS) and Mental Component Summary(MCS) scores. Both PCS and MCS are summary scores that are calculated using associated factor weights for the respective summary score applied to all eight scales. For overall ranges for PCS and MCS (no theoretical full range available), the SF-36 verion 2 utilizes norm-based scoring involving a linear T-score transformation method so that scores for each of the health domain and component summary measures have a mean of 50 and a standard deviation of 10, based on 2009 U.S. general population. Scores above and below 50 are above and velow the average.
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=23 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=20 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=9 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Quality of Life Score
Physical component summary(Change from baseline)
|
0.772 score on a scale
Standard Deviation 5.7640
|
0.556 score on a scale
Standard Deviation 6.4798
|
1.338 score on a scale
Standard Deviation 5.4218
|
|
Quality of Life Score
Mental component summary(Change from baseline)
|
4.913 score on a scale
Standard Deviation 11.1022
|
-0.930 score on a scale
Standard Deviation 8.9426
|
1.643 score on a scale
Standard Deviation 10.4183
|
SECONDARY outcome
Timeframe: Up to week 12Population: ITT Set
Proportion of participants achieving two or more consecutive platelet counts of ≥ 30,000/μL separated by at least 5 days and without the use of rescue medication
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 30,000/µL)
|
10 Participants
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to week 12Proportion of participants achieving two or more consecutive platelet counts of ≥ 50,000/μL separated by at least 5 days and without the use of rescue medication
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 50,000/µL)
|
5 Participants
|
9 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Up to week 16Population: The overall number analyzed is different each visit as patients were dropped.
The ITP Bleeding Scale(IBLS) is an immune thrombocytopenic purpura(ITP)-specific bleeding score. The IBLS comprises of 11 site-specific grades, assessed at 9 anatomical sites by history(Hx). In addition, two of these sites, skin and oral, were also assessed by physical examination(PE). These 11 grades include: skin (PE), skin(Hx), oral(PE), oral(Hx), epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage, and ranged from Grade 0 (none) to Grade 2 (marked bleeding). The grade of IBLS was transformed from categorical type to numerical type (Grade 0 to 0, Grade 1 to 1, Grade 2 to 2, and 0 being better and 2 being worst). Each subject sumed up the transformed scores across all 11 sites per visit assessment. The total overall score ranges from 0-22 with the higher score indicating worst outcome.
Outcome measures
| Measure |
SKI-O-703 200 mg BID
n=26 Participants
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 Participants
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 Participants
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Bleeding Score
End of Study(week 16)
|
0.42 score on a scale
Standard Deviation 0.974
|
0.80 score on a scale
Standard Deviation 1.005
|
0.70 score on a scale
Standard Deviation 1.160
|
|
Bleeding Score
Week 1 Day 1
|
2.15 score on a scale
Standard Deviation 2.908
|
1.29 score on a scale
Standard Deviation 2.411
|
1.75 score on a scale
Standard Deviation 2.137
|
|
Bleeding Score
Week 5
|
0.84 score on a scale
Standard Deviation 2.249
|
1.33 score on a scale
Standard Deviation 3.276
|
0.64 score on a scale
Standard Deviation 1.120
|
|
Bleeding Score
Week 9
|
1.16 score on a scale
Standard Deviation 3.986
|
0.45 score on a scale
Standard Deviation 0.759
|
0.91 score on a scale
Standard Deviation 1.640
|
|
Bleeding Score
Week 12
|
1.21 score on a scale
Standard Deviation 4.283
|
0.45 score on a scale
Standard Deviation 0.759
|
0.55 score on a scale
Standard Deviation 1.036
|
Adverse Events
SKI-O-703 200 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
SKI-O-703 400 mg BID
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SKI-O-703 200 mg BID
n=26 participants at risk
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 participants at risk
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 participants at risk
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
4.5%
1/22 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
4.5%
1/22 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/22 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/22 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/22 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
Other adverse events
| Measure |
SKI-O-703 200 mg BID
n=26 participants at risk
2 capsules of 100 mg SKI-O-703 BID (twice per day)
|
SKI-O-703 400 mg BID
n=22 participants at risk
4 capsules of 100 mg SKI-O-703 BID (twice per day)
|
Placebo
n=12 participants at risk
4 capsules of placebo BID (twice per day)
|
|---|---|---|---|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
13.6%
3/22 • Number of events 3 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
9.1%
2/22 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
9.1%
2/22 • Number of events 3 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
15.4%
4/26 • Number of events 4 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
13.6%
3/22 • Number of events 3 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
25.0%
3/12 • Number of events 5 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
9.1%
2/22 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
4.5%
1/22 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Number of events 6 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
18.2%
4/22 • Number of events 6 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
9.1%
2/22 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/12 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/22 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Vascular disorders
Haematoma
|
3.8%
1/26 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
4.5%
1/22 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
Infections and infestations
Corona virus infection
|
11.5%
3/26 • Number of events 3 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
0.00%
0/22 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
8.3%
1/12 • Number of events 1 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
|
General disorders
Asthenia
|
0.00%
0/26 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
9.1%
2/22 • Number of events 3 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
16.7%
2/12 • Number of events 2 • Up to 16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments, including those that worsen from baseline, felt to be clinically significant in the medical and scientific judgment of the investigator were to be recorded as AEs or SAEs.
|
Additional Information
Sungsil Lee/Team Leader of Clinical Development
Oscotec Inc.
Phone: +82316287624
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER