Trial Outcomes & Findings for CSTC1 for Diabetic Foot Ulcers Phase II Study (NCT NCT01813305)
NCT ID: NCT01813305
Last Updated: 2022-04-12
Results Overview
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Baseline to 14 weeks
Results posted on
2022-04-12
Participant Flow
The planned sample size was determined to be 80 versus 20 subjects (4:1 ratio) for treatment versus vehicle groups, 100 subjects in total. To ensure the completion of 100 evaluable subjects, around 125 subjects were planned to be recruited. In the actual trial, a total of 137 subjects were screened, with 124 meeting the criteria followed by randomization to CSTC1 group (n = 98) or Vehicle group (n = 26).
Participant milestones
| Measure |
CSTC1
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
26
|
|
Overall Study
COMPLETED
|
63
|
18
|
|
Overall Study
NOT COMPLETED
|
35
|
8
|
Reasons for withdrawal
| Measure |
CSTC1
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
5
|
|
Overall Study
Safety Concern
|
4
|
0
|
|
Overall Study
Ulcer became worse
|
4
|
0
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Prohibited Medication Administration or Condition Worsening
|
7
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 13.79 • n=98 Participants
|
58.6 years
STANDARD_DEVIATION 11.84 • n=26 Participants
|
58.2 years
STANDARD_DEVIATION 13.36 • n=124 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=98 Participants
|
17 Participants
n=26 Participants
|
84 Participants
n=124 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=98 Participants
|
9 Participants
n=26 Participants
|
40 Participants
n=124 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
98 Participants
n=98 Participants
|
26 Participants
n=26 Participants
|
124 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 1 ~ 1.5 cm^2
|
27 Participants
n=98 Participants
|
5 Participants
n=26 Participants
|
32 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 1.5 ~ 2 cm^2
|
11 Participants
n=98 Participants
|
4 Participants
n=26 Participants
|
15 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 2 ~ 3 cm^2
|
15 Participants
n=98 Participants
|
4 Participants
n=26 Participants
|
19 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 3 ~ 4 cm^2
|
14 Participants
n=98 Participants
|
2 Participants
n=26 Participants
|
16 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 4 ~ 5 cm^2
|
8 Participants
n=98 Participants
|
4 Participants
n=26 Participants
|
12 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 5 ~ 10 cm^2
|
15 Participants
n=98 Participants
|
4 Participants
n=26 Participants
|
19 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 10 ~ 15 cm^2
|
4 Participants
n=98 Participants
|
1 Participants
n=26 Participants
|
5 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 15 ~ 20 cm^2
|
2 Participants
n=98 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=124 Participants
|
|
Baseline Diabetic Foot Target Ulcer Size
> 20 cm^2
|
2 Participants
n=98 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=124 Participants
|
|
Maximum Grade of Foot Ulcers
Grade 1
|
15 Participants
n=98 Participants
|
4 Participants
n=26 Participants
|
19 Participants
n=124 Participants
|
|
Maximum Grade of Foot Ulcers
Grade 2
|
83 Participants
n=98 Participants
|
22 Participants
n=26 Participants
|
105 Participants
n=124 Participants
|
|
Baseline Target Ulcer Size
|
4.37 cm^2
STANDARD_DEVIATION 5.471 • n=98 Participants
|
5.15 cm^2
STANDARD_DEVIATION 5.531 • n=26 Participants
|
4.53 cm^2
STANDARD_DEVIATION 5.470 • n=124 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 weeksPopulation: All randomized subjects who have received at least one dose of study medication.
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at the coming visits 2 weeks apart. The treatment period is until 12 weeks or up to confirmation of complete ulcer closure. Subjects with complete ulcer closure at Week 12 and confirmed at Week 14 were considered as success.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Number of Participants With Complete Ulcer Closure During the Treatment Period
|
32 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized subjects who have received at least one dose of study medication.
Defined as the time to complete ulcer closure.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
The Ulcer Closure Time
|
87 Days
Standard Error 2.2
|
92 Days
Standard Error 3.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements observed for at the last two consecutive study visits 2 weeks apart. The count of participants with complete ulcer closure at each post-treatment visit is provided.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 1
|
0 Participants
|
0 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 2
|
0 Participants
|
0 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 3
|
0 Participants
|
0 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 4
|
0 Participants
|
0 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 6
|
2 Participants
|
1 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 8
|
9 Participants
|
1 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 10
|
13 Participants
|
1 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 12
|
22 Participants
|
2 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 14
|
32 Participants
|
4 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 16
|
35 Participants
|
7 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 20
|
35 Participants
|
7 Participants
|
|
The Accumulated Participant Counts With Complete Ulcer Closure
Week 24
|
36 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). This proportion was then multiplied by 100 to calculate the percentage change in ulcer size for each post-treatment visit. The percentage change in ulcer size for each post-treatment visit are presented.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 1
|
-15.2 percent change
Standard Deviation 28.31
|
-16.3 percent change
Standard Deviation 25.09
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 2
|
-28.3 percent change
Standard Deviation 30.32
|
-21.7 percent change
Standard Deviation 32.82
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 3
|
-36.3 percent change
Standard Deviation 34.93
|
-29.1 percent change
Standard Deviation 41.00
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 4
|
-46.6 percent change
Standard Deviation 35.15
|
-32.8 percent change
Standard Deviation 36.90
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 6
|
-53.6 percent change
Standard Deviation 40.13
|
-44.8 percent change
Standard Deviation 41.11
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 8
|
-56.7 percent change
Standard Deviation 49.96
|
-47.0 percent change
Standard Deviation 46.67
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 10
|
-61.7 percent change
Standard Deviation 47.01
|
-51.8 percent change
Standard Deviation 44.85
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 12
|
-66.3 percent change
Standard Deviation 41.91
|
-54.2 percent change
Standard Deviation 56.52
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 14
|
-69.1 percent change
Standard Deviation 39.09
|
-57.6 percent change
Standard Deviation 57.54
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 16
|
-69.8 percent change
Standard Deviation 38.40
|
-59.1 percent change
Standard Deviation 60.05
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 20
|
-70.4 percent change
Standard Deviation 38.60
|
-59.1 percent change
Standard Deviation 60.05
|
|
Percentage Change in Ulcer Size for Each Post-treatment Visit
Week 24
|
-70.2 percent change
Standard Deviation 38.52
|
-59.0 percent change
Standard Deviation 59.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication, whether or not related to the study medication. AE data was collected from Screening visit to Final visit (up to 24 weeks).
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Number of Participants With Adverse Events
|
80 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: All randomized patients who have received at least one dose study medication.
Physical examinations in this study included the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others. Physical examinations were conducted from Screening visit to Final visit (up to 24 weeks). If at least one of physical examinations was identified in the subject, the subject was included in physical abnormalities calculation.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Number of Participants With Physical Abnormality Finding at the Visits
Baseline (Day 1)
|
57 participants
|
18 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 1
|
57 participants
|
18 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 2
|
57 participants
|
18 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 3
|
59 participants
|
16 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 4
|
57 participants
|
16 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 6
|
57 participants
|
17 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 8
|
52 participants
|
16 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 10
|
45 participants
|
16 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 12
|
41 participants
|
16 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 14
|
43 participants
|
12 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 16
|
42 participants
|
12 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 20
|
18 participants
|
2 participants
|
|
Number of Participants With Physical Abnormality Finding at the Visits
Week 24
|
15 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 weeksPopulation: All randomized patients who have received at least one dose study medication.
Laboratory examination to be measured in this study consisted of hematology (hemoglobin, hematocrit, RBC, platelet, WBC with differential counts) and biochemistry (Aspartate Transaminase (AST), Alanine Transaminase (ALT), fasting glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin). The laboratory examinations were conducted at the Screening visit, baseline, and Week 12. Patients' laboratory change from baseline to Week 12 was documented as relieved, unchanged, worsened (MH), or worsened (AE). The "worsened" means that the laboratory values were normal or non clinically significant (NCS) at baseline but change to clinically significant at Week 12. If the worsen situation was found, the clinically significant worsening changes were classified as related to medical history (MH) or adverse events (AE).
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
White blood cells (10^9/L) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
White blood cells (10^9/L) · Unchanged
|
81 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
White blood cells (10^9/L) · Worsened (MH)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
White blood cells (10^9/L) · Worsened (AE)
|
5 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Neutrophils (%) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Neutrophils (%) · Unchanged
|
84 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Neutrophils (%) · Worsened (MH)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Neutrophils (%) · Worsened (AE)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Eosinophils (%) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Eosinophils (%) · Unchanged
|
87 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Eosinophils (%) · Worsened (MH)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Eosinophils (%) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Basophils (%) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Basophils (%) · Unchanged
|
87 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Basophils (%) · Worsened (MH)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Basophils (%) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Lymphocytes (%) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Lymphocytes (%) · Unchanged
|
83 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Lymphocytes (%) · Worsened (MH)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Lymphocytes (%) · Worsened (AE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Monocytes (%) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Monocytes (%) · Unchanged
|
87 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Monocytes (%) · Worsened (MH)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Monocytes (%) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Red Blood Cells (^12/L) · Relieved
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Red Blood Cells (^12/L) · Unchanged
|
81 Participants
|
21 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Red Blood Cells (^12/L) · Worsened (MH)
|
5 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Red Blood Cells (^12/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin (g/mL) · Relieved
|
3 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin (g/mL) · Unchanged
|
80 Participants
|
21 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin (g/mL) · Worsened (MH)
|
5 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin (g/mL) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hematocrit (%) · Relieved
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hematocrit (%) · Unchanged
|
82 Participants
|
21 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hematocrit (%) · Worsened (MH)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hematocrit (%) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Platelets (10^9/L) · Relieved
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Platelets (10^9/L) · Unchanged
|
86 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Platelets (10^9/L) · Worsened (MH)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Platelets (10^9/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin A1C (%) · Relieved
|
5 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin A1C (%) · Unchanged
|
79 Participants
|
21 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin A1C (%) · Worsened (MH)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Hemoglobin A1C (%) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Aspartate Aminotransferase (U/L) · Relieved
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Aspartate Aminotransferase (U/L) · Unchanged
|
85 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Aspartate Aminotransferase (U/L) · Worsened (MH)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Aspartate Aminotransferase (U/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Alanine Aminotransferase (U/L) · Relieved
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Alanine Aminotransferase (U/L) · Unchanged
|
86 Participants
|
22 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Alanine Aminotransferase (U/L) · Worsened (MH)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Alanine Aminotransferase (U/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Blood Urea Nitrogen (U/L) · Relieved
|
6 Participants
|
2 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Blood Urea Nitrogen (U/L) · Unchanged
|
77 Participants
|
19 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Blood Urea Nitrogen (U/L) · Worsened (MH)
|
5 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Blood Urea Nitrogen (U/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Creatinine (umol/L) · Relieved
|
6 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Creatinine (umol/L) · Unchanged
|
78 Participants
|
21 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Creatinine (umol/L) · Worsened (MH)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Creatinine (umol/L) · Worsened (AE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Glucose (mg/dL) · Relieved
|
13 Participants
|
1 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Glucose (mg/dL) · Unchanged
|
66 Participants
|
18 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Glucose (mg/dL) · Worsened (MH)
|
9 Participants
|
3 Participants
|
|
Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
Glucose (mg/dL) · Worsened (AE)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, blood pressure (systolic/diastolic) were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Blood Pressure Change From Baseline to Week 24
Systolic Blood Pressure [mmHg]
|
-3.67 mmHg
Standard Deviation 27.088
|
-20.00 mmHg
Standard Deviation 34.137
|
|
Blood Pressure Change From Baseline to Week 24
Diastolic Blood Pressure [mmHg]
|
1.41 mmHg
Standard Deviation 13.882
|
-6.25 mmHg
Standard Deviation 4.646
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, pulse rates were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Outcome measures
| Measure |
CSTC1
n=27 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=4 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Pulse Rate Change From Baseline to Week 24
|
4.00 beats/min
Standard Deviation 9.899
|
-1.25 beats/min
Standard Deviation 9.323
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, body temperature were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Outcome measures
| Measure |
CSTC1
n=27 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=4 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Body Temperature Change From Baseline to Week 24
|
0.08 degrees Celsius
Standard Deviation 0.468
|
0.33 degrees Celsius
Standard Deviation 0.377
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Vital signs measurement consisted of blood pressures, pulse rate, respiratory rate, and body temperature. Among them, respiratory rate were obtained after the subject has been at rest for at least 5 minutes in a sitting position. The vital sign data was collected from Screening visit to Final visit (up to 24 weeks). The mean changes of Final visit to baseline in vital signs were presented (value at 24 weeks minus value at baseline).
Outcome measures
| Measure |
CSTC1
n=27 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=4 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Respiratory Rate Change From Baseline to Week 24
|
-0.11 breaths/min
Standard Deviation 1.672
|
-3.25 breaths/min
Standard Deviation 3.862
|
POST_HOC outcome
Timeframe: 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 50% reduction in target ulcer size was measured from Screening visit to Final visit (up to 24 weeks).
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Time to Achieve ≥ 50% Reduction in Target Ulcer Size
|
42 Days
Standard Deviation 3.3
|
52 Days
Standard Deviation 7.1
|
POST_HOC outcome
Timeframe: 12 weeksPopulation: All randomized patients who have received at least one dose of study medication.
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). A subject who had target ulcer closure ≥ 50% was counted as a responder. The non-responders included subjects whose target ulcer closure size less than 50% before 12 weeks.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
The Response Rate of the Target Ulcer Size Reduction ≥ 50%
Responder
|
77 Participants
|
18 Participants
|
|
The Response Rate of the Target Ulcer Size Reduction ≥ 50%
Non-Responder
|
21 Participants
|
8 Participants
|
POST_HOC outcome
Timeframe: 24 weeksPopulation: All randomized patients who have received at least one dose of study medication.
The proportion of ulcer closure is calculated as (Ulcer size at post-treatment visit - Ulcer size at baseline)/(Ulcer size at baseline). Time to achieve ≥ 90% reduction in target ulcer size was analyzed in the subjects.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Time to Achieve ≥90% Reduction in Target Ulcer Size
|
73 Days
Standard Deviation 2.9
|
84 Days
Standard Deviation 4.4
|
POST_HOC outcome
Timeframe: 12 weeksPopulation: All randomized patients who have received at least one dose of study medication.
Subjects with ulcer closure size ≥ 90% compared to the baseline at a Week 12 were considered as a responder. A subject whose target ulcer size reduction was less than 90% was counted as a non-responder. The percentage of repsonders and non-responders were presented.
Outcome measures
| Measure |
CSTC1
n=98 Participants
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 Participants
Matched vehicle, topical, two times daily
|
|---|---|---|
|
The Response Rate of the Target Ulcer Size Reduction ≥ 90%
Responder
|
49 Participants
|
12 Participants
|
|
The Response Rate of the Target Ulcer Size Reduction ≥ 90%
Non-Responder
|
49 Participants
|
14 Participants
|
Adverse Events
CSTC1
Serious events: 20 serious events
Other events: 44 other events
Deaths: 2 deaths
CSTC1 Matched Vehicle
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CSTC1
n=98 participants at risk
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 participants at risk
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
5.1%
5/98 • Number of events 5 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
3.8%
1/26 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Abdominal sepsis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Wound sepsis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Diabetic gangrene
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/98 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
3.8%
1/26 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Nervous system disorders
Orthostatic hypotension
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Pulmonary sepsis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Application site cellulitis
|
2.0%
2/98 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Pyelonephritis acute
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Osteomyelitis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
3.8%
1/26 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
General disorders
Impaired healing
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Streptococcal sepsis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Sepsis
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Septic shock
|
1.0%
1/98 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/98 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
3.8%
1/26 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
Other adverse events
| Measure |
CSTC1
n=98 participants at risk
CSTC1 (vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof), topical, two times daily
|
CSTC1 Matched Vehicle
n=26 participants at risk
Matched vehicle, topical, two times daily
|
|---|---|---|
|
Eye disorders
Cataract
|
5.1%
5/98 • Number of events 5 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
General disorders
Application site erosion
|
6.1%
6/98 • Number of events 7 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
General disorders
Peripheral swelling
|
4.1%
4/98 • Number of events 4 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
7.7%
2/26 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
7/98 • Number of events 7 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
7.7%
2/26 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Injury, poisoning and procedural complications
Limb injury
|
17.3%
17/98 • Number of events 31 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
26.9%
7/26 • Number of events 12 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.1%
5/98 • Number of events 5 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
3.8%
1/26 • Number of events 1 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.0%
2/98 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
7.7%
2/26 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Injury, poisoning and procedural complications
Skin wound
|
2.0%
2/98 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
7.7%
2/26 • Number of events 2 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
6/98 • Number of events 6 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
0.00%
0/26 • AE data was collected from Screening visit to Final visit (up to 24 weeks)
All enrolled subjects were used for the analysis of AE and SAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place