Trial Outcomes & Findings for A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa (NCT NCT03836001)
NCT ID: NCT03836001
Last Updated: 2023-02-14
Results Overview
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
baseline and after two months of treatment
Results posted on
2023-02-14
Participant Flow
Four participants were consented but failed initial screening and were not allocated to treatment. Two participants failed initial screening but were re-screened and entered the study. A protocol amendment in May 2020 changed the duration of the follow-up period from 12 months to 3 months.
Participant milestones
| Measure |
Placebo Oral Tablet
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Open-label Extension
3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|---|
|
Blinded Phase (2 Months)
STARTED
|
12
|
12
|
0
|
|
Blinded Phase (2 Months)
COMPLETED
|
12
|
10
|
0
|
|
Blinded Phase (2 Months)
NOT COMPLETED
|
0
|
2
|
0
|
|
Washout (1 Month)
STARTED
|
12
|
10
|
0
|
|
Washout (1 Month)
COMPLETED
|
12
|
10
|
0
|
|
Washout (1 Month)
NOT COMPLETED
|
0
|
0
|
0
|
|
Open-label Extension (3 or 12 Months)
STARTED
|
0
|
0
|
10
|
|
Open-label Extension (3 or 12 Months)
Entered 12-month Follow-up Period
|
0
|
0
|
2
|
|
Open-label Extension (3 or 12 Months)
Entered 3-month Follow-up Period
|
0
|
0
|
8
|
|
Open-label Extension (3 or 12 Months)
COMPLETED
|
0
|
0
|
8
|
|
Open-label Extension (3 or 12 Months)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo Oral Tablet
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Open-label Extension
3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|---|
|
Blinded Phase (2 Months)
Adverse Event
|
0
|
1
|
0
|
|
Blinded Phase (2 Months)
Physician Decision
|
0
|
1
|
0
|
|
Open-label Extension (3 or 12 Months)
Lost to Follow-up
|
0
|
0
|
1
|
|
Open-label Extension (3 or 12 Months)
Enrolled in other clinical study
|
0
|
0
|
1
|
Baseline Characteristics
A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
22 years
n=7 Participants
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Epidermolysis Bullosa (EB) Subtype
EB simplex
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Epidermolysis Bullosa (EB) Subtype
Junctional EB
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epidermolysis Bullosa (EB) Subtype
Dominant dystrophic EB
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Epidermolysis Bullosa (EB) Subtype
Recessive dystrophic EB
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Average Itch Numeric Rating Scale (AI-NRS)
|
6 score on a scale
n=5 Participants
|
7 score on a scale
n=7 Participants
|
6 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after two months of treatmentPopulation: Data were analyzed using the last observation carried forward method (LCOF)
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Number of Patients Who Achieve at Least a 3-point Reduction in AI-NRS.
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and after two months of treatmentPopulation: Data were analyzed using the last observation carried forward method (LCOF)
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Number of Patients Who Achieve at Least a 2-point Reduction in AI-NRS.
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and after two months of treatmentPopulation: Data were analyzed using the last observation carried forward method (LCOF)
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Number of Patients Who Achieve at Least a 4-point Reduction in AI-NRS.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and after two months of treatmentPopulation: Data were analyzed using the last observation carried forward method (LCOF)
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Number of Patients Who Achieve at Least a 30% Reduction in AI-NRS.
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and after two months of treatmentPopulation: Data were analyzed using the last observation carried forward method (LCOF)
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Number of Patients Who Achieve at Least a 50% Reduction in AI-NRS.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean WI-NRS value of each participant.
Participants will be asked to complete a daily itch diary with their worst itch numeric rating scale (WI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Weekly Worst Itch NRS
baseline
|
6.1 score on a scale
Standard Deviation 2.3
|
7.3 score on a scale
Standard Deviation 1.6
|
|
Weekly Worst Itch NRS
week 1
|
6.0 score on a scale
Standard Deviation 2.3
|
6.3 score on a scale
Standard Deviation 1.7
|
|
Weekly Worst Itch NRS
week 2
|
6.1 score on a scale
Standard Deviation 2.0
|
5.9 score on a scale
Standard Deviation 1.6
|
|
Weekly Worst Itch NRS
week 3
|
6.5 score on a scale
Standard Deviation 1.9
|
5.7 score on a scale
Standard Deviation 1.8
|
|
Weekly Worst Itch NRS
week 4
|
6.4 score on a scale
Standard Deviation 1.7
|
5.6 score on a scale
Standard Deviation 2.0
|
|
Weekly Worst Itch NRS
week 5
|
6.4 score on a scale
Standard Deviation 2.2
|
5.7 score on a scale
Standard Deviation 2.2
|
|
Weekly Worst Itch NRS
week 6
|
6.0 score on a scale
Standard Deviation 2.3
|
5.8 score on a scale
Standard Deviation 2.1
|
|
Weekly Worst Itch NRS
week 7
|
6.0 score on a scale
Standard Deviation 2.2
|
5.6 score on a scale
Standard Deviation 2.2
|
|
Weekly Worst Itch NRS
week 8
|
6.0 score on a scale
Standard Deviation 2.4
|
5.4 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean AI-NRS value of each participant.
Participants will be asked to complete a daily itch diary with their average itch numeric rating scale (AI-NRS) over the past 24 hours. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Weekly AI-NRS
baseline
|
5.3 score on a scale
Standard Deviation 2.2
|
6.3 score on a scale
Standard Deviation 2.3
|
|
Weekly AI-NRS
week 1
|
5.1 score on a scale
Standard Deviation 2.2
|
5.6 score on a scale
Standard Deviation 2.2
|
|
Weekly AI-NRS
week 2
|
5.3 score on a scale
Standard Deviation 1.9
|
5.6 score on a scale
Standard Deviation 1.9
|
|
Weekly AI-NRS
week 3
|
5.5 score on a scale
Standard Deviation 2.0
|
5.2 score on a scale
Standard Deviation 2.4
|
|
Weekly AI-NRS
week 4
|
5.4 score on a scale
Standard Deviation 1.7
|
5.2 score on a scale
Standard Deviation 2.2
|
|
Weekly AI-NRS
week 5
|
5.2 score on a scale
Standard Deviation 2.0
|
5.1 score on a scale
Standard Deviation 2.4
|
|
Weekly AI-NRS
week 6
|
5.0 score on a scale
Standard Deviation 2.1
|
5.1 score on a scale
Standard Deviation 2.6
|
|
Weekly AI-NRS
week 7
|
4.8 score on a scale
Standard Deviation 1.7
|
5.2 score on a scale
Standard Deviation 2.7
|
|
Weekly AI-NRS
week 8
|
4.8 score on a scale
Standard Deviation 2.0
|
5.0 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: month 2Population: Participants who completed the month 2 assessment are included in the analysis.
PGIC categorized as "Very much better", "Moderately better", "A little better", "No change", "A little worse", "Moderately worse", and "Very much worse".
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=10 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
Very much better
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC)
Moderately better
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
A little better
|
5 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGIC)
No change
|
5 Participants
|
5 Participants
|
|
Patient Global Impression of Change (PGIC)
A little worse
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Moderately worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: month 2Population: Participants who enrolled after protocol amendment adding this outcome measure are included in the analysis
Severity of itch over past 7 days assessed as Very Severe, Severe, Moderate, Mild, or None. Change is reported as the number of participants with 3-category improvement, 2-category improvement, 1-category improvement, no change, or worse.
Outcome measures
| Measure |
Placebo Oral Tablet
n=5 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=4 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Change in Static Participant Assessment of Itch
3-category improvement
|
0 Participants
|
1 Participants
|
|
Change in Static Participant Assessment of Itch
2-category improvement
|
0 Participants
|
1 Participants
|
|
Change in Static Participant Assessment of Itch
1-category improvement
|
2 Participants
|
0 Participants
|
|
Change in Static Participant Assessment of Itch
No change
|
3 Participants
|
2 Participants
|
|
Change in Static Participant Assessment of Itch
Worse
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: baseline and week 1, 2, 3, 4, 5, 6, 7, and 8Population: Daily diary data were averaged weekly. The missing weekly data have been imputed by the mean Dressing/Bathing-NRS value of each participant.
Participants will be asked to complete a daily itch diary with their itch Numeric Rating Scale (NRS) during dressing/bathing. Score range: 0 to 10, higher scores mean more itching.
Outcome measures
| Measure |
Placebo Oral Tablet
n=12 Participants
Patients undergo two months of dosing with placebo followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
Serlopitant Tablet
n=12 Participants
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients may continue in a 3-month open label extension with serlopitant at 5 mg (taken by mouth) daily for continued safety monitoring.
|
|---|---|---|
|
Dressing/Bathing NRS
week 5
|
5.6 score on a scale
Standard Deviation 2.6
|
5.5 score on a scale
Standard Deviation 2.9
|
|
Dressing/Bathing NRS
baseline
|
5.3 score on a scale
Standard Deviation 2.6
|
6.8 score on a scale
Standard Deviation 3.1
|
|
Dressing/Bathing NRS
week 1
|
5.1 score on a scale
Standard Deviation 2.3
|
5.7 score on a scale
Standard Deviation 3.0
|
|
Dressing/Bathing NRS
week 2
|
5.0 score on a scale
Standard Deviation 2.1
|
6.0 score on a scale
Standard Deviation 2.8
|
|
Dressing/Bathing NRS
week 3
|
5.5 score on a scale
Standard Deviation 2.5
|
5.4 score on a scale
Standard Deviation 3.1
|
|
Dressing/Bathing NRS
week 4
|
5.4 score on a scale
Standard Deviation 2.7
|
5.1 score on a scale
Standard Deviation 3.1
|
|
Dressing/Bathing NRS
week 6
|
5.6 score on a scale
Standard Deviation 2.7
|
5.5 score on a scale
Standard Deviation 3.2
|
|
Dressing/Bathing NRS
week 7
|
5.6 score on a scale
Standard Deviation 2.8
|
5.4 score on a scale
Standard Deviation 3.2
|
|
Dressing/Bathing NRS
week 8
|
5.3 score on a scale
Standard Deviation 2.7
|
5.4 score on a scale
Standard Deviation 3.2
|
Adverse Events
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serlopitant Tablet
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Open-label Extension
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Oral Tablet
n=12 participants at risk
Patients undergo two months of dosing with a placebo followed by one month of wash-out. All patients were invited to participate in an open-label extension study.
|
Serlopitant Tablet
n=12 participants at risk
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients were invited to participate in an open-label extension study.
|
Open-label Extension
n=10 participants at risk
Participants took oral serlopitant 5mg daily for either 12 months (for those who enrolled before May 2020) or 3 months (for those who registered after May 2020).
|
|---|---|---|---|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Bacteremia (sepsis)
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
Other adverse events
| Measure |
Placebo Oral Tablet
n=12 participants at risk
Patients undergo two months of dosing with a placebo followed by one month of wash-out. All patients were invited to participate in an open-label extension study.
|
Serlopitant Tablet
n=12 participants at risk
Patients who will undergo two months of Serlopitant dosing, followed by one month of wash-out. All patients were invited to participate in an open-label extension study.
|
Open-label Extension
n=10 participants at risk
Participants took oral serlopitant 5mg daily for either 12 months (for those who enrolled before May 2020) or 3 months (for those who registered after May 2020).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Up to 15 months
|
16.7%
2/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
|
Gastrointestinal disorders
Soft stool
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
General disorders
Chest pain
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Hepatobiliary disorders
Elevated ALT
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Hepatobiliary disorders
Elevated GGT
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Investigations
Elevated prolactin
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to 15 months
|
16.7%
2/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
General disorders
Fatigue
|
8.3%
1/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Nervous system disorders
Chronic headaches
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Endocrine disorders
Type 2 diabetes
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Eye disorders
Corneal abrasion
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
16.7%
2/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Infections and infestations
Swollen cheek due to wound
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
General disorders
Flu-like symptoms
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Enlarged lymph nodes
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Worsening anemia
|
16.7%
2/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Cracked tooth
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
General disorders
Inflamed cyst
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Skin and subcutaneous tissue disorders
Irritant dermatitis around G-tube
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Hematuria
|
0.00%
0/12 • Up to 15 months
|
16.7%
2/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Renal and urinary disorders
Kidney stone surgery
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Renal and urinary disorders
Microscopic pyuria
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
|
Infections and infestations
The COVID-19 infection
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
20.0%
2/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Enlarged parotid gland
|
0.00%
0/12 • Up to 15 months
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Blood and lymphatic system disorders
Elevated leukocyte esterase
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
|
Gastrointestinal disorders
Pruritus of pharynx
|
8.3%
1/12 • Up to 15 months
|
0.00%
0/12 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place