Trial Outcomes & Findings for Study of Alwextin® Cream in Treating Epidermolysis Bullosa (NCT NCT00825565)
NCT ID: NCT00825565
Last Updated: 2018-02-28
Results Overview
A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease "spread" with weighting factors.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
baseline and then every 4 weeks for a total of 12 weeks
Results posted on
2018-02-28
Participant Flow
Subjects were identified at regularly scheduled clinic visits with the Principal Investigator at Children's Memorial Hospital.
Subjects were instructed to discontinue use of allantoin 1.5% cream (Alwyn) for at least 30 days prior to initiating the study medication, allantoin 3% cream (Alwextin).
Participant milestones
| Measure |
Allantoin 3% Cream
This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Alwextin® Cream in Treating Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
Allantoin 3% Cream
n=8 Participants
This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
3.3 years
STANDARD_DEVIATION 2.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: baseline and then every 4 weeks for a total of 12 weeksPopulation: Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.
A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease "spread" with weighting factors.
Outcome measures
| Measure |
Allantoin 3% Cream
n=8 Participants
Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
Upper Limbs
|
Trunk
|
Lower Limbs
|
|---|---|---|---|---|
|
Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
Baseline assessment
|
57.25 percentage of BSA involvement
Standard Deviation 19.1
|
—
|
—
|
—
|
|
Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
Week 4 assessment
|
39.40 percentage of BSA involvement
Standard Deviation 24.1
|
—
|
—
|
—
|
|
Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
Week 8 assessment
|
27.25 percentage of BSA involvement
Standard Deviation 17.9
|
—
|
—
|
—
|
|
Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
Week 12 assessment
|
25.45 percentage of BSA involvement
Standard Deviation 21.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and then every 4 weeks for a total of 12 weeksPopulation: Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.
EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream. Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital.
Outcome measures
| Measure |
Allantoin 3% Cream
n=8 Participants
Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
Upper Limbs
|
Trunk
|
Lower Limbs
|
|---|---|---|---|---|
|
Target Wound Size Reduction or Closure
Baseline assessment
|
8 number of unhealed target wounds
|
—
|
—
|
—
|
|
Target Wound Size Reduction or Closure
Week 12 assessment
|
1 number of unhealed target wounds
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and then every 4 weeks for a total of 12 weeksPopulation: One subject discontinued after week 3. One subject discontinued at Month 2. Only data presented for subjects who used cream on entire body for the entire month was used in the analysis.
The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a "global impression." This scale produced a score with the following correlations: 0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)
Outcome measures
| Measure |
Allantoin 3% Cream
n=8 Participants
Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
Upper Limbs
|
Trunk
|
Lower Limbs
|
|---|---|---|---|---|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 6
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 1
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 1
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 2
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 3
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 4
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 5
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 6
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 7
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 8
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 9
|
3 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Baseline · PGAS score of 10
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 1
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 2
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 3
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 4
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 5
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 7
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 8
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 9
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 1 · PGAS score of 10
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 2
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 3
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 4
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 5
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 6
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 7
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 8
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 9
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 2 · PGAS score of 10
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 1
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 2
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 3
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 4
|
2 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 5
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 6
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 7
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 8
|
0 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 9
|
1 Participants
|
—
|
—
|
—
|
|
Physician Global Assessment of Severity (PGAS)
Month 3 · PGAS score of 10
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and at 12 weeksPopulation: Subjects who used cream on entire body for the entire month was used in the analysis.
In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated. This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe
Outcome measures
| Measure |
Allantoin 3% Cream
n=8 Participants
Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
Upper Limbs
n=8 Participants
|
Trunk
n=8 Participants
|
Lower Limbs
n=8 Participants
|
|---|---|---|---|---|
|
Physician Assessment of Individual Signs
Milia- Month 3 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Erythema- Month 3 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia-Baseline · Clear
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Physician Assessment of Individual Signs
Milia-Baseline · Almost Clear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia-Baseline · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia-Baseline · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia-Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia- Month 3 · Clear
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Physician Assessment of Individual Signs
Milia- Month 3 · Almost Clear
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia- Month 3 · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Milia- Month 3 · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pain-Month 3 · Clear
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Pruritis-Baseline · Severe
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pruritus-Month 3 · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pruritus-Month 3 · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting-Baseline · Clear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Erythema- Month 3 · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting- Month 3 · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pruritis-Baseline · Almost Clear
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Physician Assessment of Individual Signs
Pruritis-Baseline · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Erythema-Baseline · Clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pain-Baseline · Clear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pain-Baseline · Almost Clear
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pain-Baseline · Mild
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pain-Baseline · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Pain-Baseline · Severe
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Physician Assessment of Individual Signs
Pain-Month 3 · Almost Clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pain-Month 3 · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pain-Month 3 · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pain-Month 3 · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pruritis-Baseline · Clear
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Pruritis-Baseline · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Pruritus-Month 3 · Clear
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Pruritus-Month 3 · Almost Clear
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Pruritus-Month 3 · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions-Baseline · Clear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions-Baseline · Almost Clear
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions-Baseline · Mild
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions-Baseline · Moderate
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions-Baseline · Severe
|
0 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions- Month 3 · Clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions- Month 3 · Almost Clear
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions- Month 3 · Mild
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions- Month 3 · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Blisters/Erosions- Month 3 · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting-Baseline · Almost Clear
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting-Baseline · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting-Baseline · Moderate
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting-Baseline · Severe
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting- Month 3 · Clear
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting- Month 3 · Almost Clear
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting- Month 3 · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Oozing/Weeping/Crusting- Month 3 · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Erythema-Baseline · Almost Clear
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Physician Assessment of Individual Signs
Erythema-Baseline · Mild
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Physician Assessment of Individual Signs
Erythema-Baseline · Moderate
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Erythema-Baseline · Severe
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Physician Assessment of Individual Signs
Erythema- Month 3 · Clear
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Physician Assessment of Individual Signs
Erythema- Month 3 · Almost Clear
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Physician Assessment of Individual Signs
Erythema- Month 3 · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Allantoin 3% Cream
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Allantoin 3% Cream
n=8 participants at risk
This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
|
|---|---|
|
Skin and subcutaneous tissue disorders
red, itchy skin
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
General disorders
fever
|
25.0%
2/8 • Number of events 2 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
Skin and subcutaneous tissue disorders
red spots on right foot
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
Skin and subcutaneous tissue disorders
red spots on left foot
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
|
Gastrointestinal disorders
hematemesis
|
12.5%
1/8 • Number of events 1 • For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.
AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. SAE meets any of these criteria: causes death, hospitalization, disability, or birth defect, is life-threatening, is an important medical event that may require intervention to prevent these outcomes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place