Trial Outcomes & Findings for Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis (NCT NCT03770273)
NCT ID: NCT03770273
Last Updated: 2024-12-17
Results Overview
The Mastocytosis Quality of Life Questionnaire (MC-QoL) is a validated health-related quality of life (QoL) survey for patients with mastocytosis that consists of 27 items and is divided into four domains: symptoms, social life/functioning, emotions, and skin. Each item has five options scored from 0-4 for a total minimum score of zero and maximum score of 108. The raw scores were transformed to a 0 to 100 scale. The overall disease impairment on QoL is measured by assessing both the total score and the scores of each domain with higher scores of 25% or greater indicating a higher QoL impairment. The percent change in QoL from baseline to 16 weeks post-initiation of study for participants was computed as \[(Baseline QoL - 16-week QoL)/Baseline QoL\] × 100\]. Positive value indicates improvement.
COMPLETED
PHASE2
21 participants
Baseline and 16-week post-initiation of study
2024-12-17
Participant Flow
21 participants were enrolled in the study and five participants were deemed ineligible and excluded from study
Participant milestones
| Measure |
Drug: Sarilumab
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Drug: Sarilumab
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis
Baseline characteristics by cohort
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=8 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16-week post-initiation of studyPopulation: Modified Intent-to-Treat (mITT) participants who completed questionnaire during the blinded phase of the study. One participant did not complete study during the blinded phase so was excluded from analysis.
The Mastocytosis Quality of Life Questionnaire (MC-QoL) is a validated health-related quality of life (QoL) survey for patients with mastocytosis that consists of 27 items and is divided into four domains: symptoms, social life/functioning, emotions, and skin. Each item has five options scored from 0-4 for a total minimum score of zero and maximum score of 108. The raw scores were transformed to a 0 to 100 scale. The overall disease impairment on QoL is measured by assessing both the total score and the scores of each domain with higher scores of 25% or greater indicating a higher QoL impairment. The percent change in QoL from baseline to 16 weeks post-initiation of study for participants was computed as \[(Baseline QoL - 16-week QoL)/Baseline QoL\] × 100\]. Positive value indicates improvement.
Outcome measures
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=7 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Percent Change in Quality of Life (QoL) Using Mastocytosis Quality of Life Questionnaire (MC-QoL)
|
38.98 percentage of change in quality of life
Interval 28.83 to 49.13
|
33.02 percentage of change in quality of life
Interval 22.17 to 43.88
|
PRIMARY outcome
Timeframe: Up to 32 weeks post initiation of studyPopulation: Modified Intent-to-Treat (mITT) participants who completed questionnaire during the blinded phase of the study. One participant did not complete study during the blinded phase so was excluded from analysis.
Severity of adverse event by grade using Terminology Criteria for Adverse Events (CTCAE) version 5.0: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activity of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living (ADL). Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event
Outcome measures
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=7 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Number of Participants With Adverse Events by Grade
Grade 1
|
7 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events by Grade
Grade 2
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events by Grade
Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events by Grade
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events by Grade
Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16-week post-initiation of studyPopulation: Modified Intent-to-Treat (mITT) participants who completed questionnaire during the blinded phase of the study. One participant did not complete study during the blinded phase so was excluded from analysis.
The Memorial Symptom Assessment Scale (MSAS) is used to evaluate a patient's experience with 32 symptoms over the course of the previous week. Symptoms are evaluated by severity (0 = not at all to 4 = very severe) and distress (0 = not at all to 4 = very much\] for eight of the symptoms, and for severity, distress, and frequency (0 = not at all to 4 = almost constantly) for the remaining 24 symptoms for a total minimum score of zero and maximum score of 352. Higher score indicates worsening condition. The result is calculated by taking the average of the scores for the 32 questions for baseline and week 16 post initiation of study. The percent change in quality of life (QoL) from baseline to 16 weeks post-initiation of study for participants was computed as \[(Baseline QoL - 16-week QoL)/Baseline QoL\] × 100\]. Positive value indicates improvement.
Outcome measures
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=7 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Percent Change in Quality of Life (QoL) Using the Memorial Symptom Assessment Scale (MSAS)
|
0.767 percentage of change in quality of life
Interval 0.54 to 0.99
|
0.503 percentage of change in quality of life
Interval 0.26 to 0.74
|
SECONDARY outcome
Timeframe: Baseline and 16-week post-initiation of studyPopulation: Modified Intent-to-Treat (mITT) participants who completed questionnaire during the blinded phase of the study. One participant did not complete study during the blinded phase so was excluded from analysis.
The Mastocytosis Quality of Life Questionnaire (MQLQ) is disease specific quality of life questionnaire consisting of 49 questions to assess the effect of mastocytosis on daily life. It includes the role of mastocytosis in 8 domains: fatigue and mental health, anaphylaxis, bone symptoms, unfamiliarity (low awareness), flushing, general symptoms, skin symptoms, and triggers. Each item in the 49 questions has seven options scored from 0-6 with a minimum total score of zero and a maximum total score of 294. Higher score indicates worsening condition. The result is calculated by summing scores from all 49 items for baseline and week 16 post initiation of study. The percent change in QoL from baseline to 16 weeks post-initiation of study for participants was computed as \[(Baseline QoL - 16-week QoL)/Baseline QoL\] × 100\]. Positive value indicates improvement.
Outcome measures
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=7 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Percent Change in Quality of Life (QoL) Using Mastocytosis Quality of Life Questionnaire (MQLQ)
|
111.02 percentage of change in quality of life
Interval 88.51 to 133.53
|
100.26 percentage of change in quality of life
Interval 76.19 to 124.33
|
SECONDARY outcome
Timeframe: Baseline and 16-week post-initiation of studyPopulation: Modified Intent-to-Treat (mITT) participants who completed questionnaire during the blinded phase of the study. One participant did not complete study during the blinded phase so was excluded from analysis.
The Mastocytosis Symptoms Assessment Form (MSAF) is a 22-item questionnaire that assesses the severity of symptoms with an 11-point numeric rating scale, where "0 = No symptom" and "10 = Worst imaginable symptom" for a total minimum score of zero and total maximum score of 220. Higher score indicates worsening condition. The result is calculated by summing scores from all 22 items for baseline and week 16 post initiation of study. The percent change in QoL from baseline to 16 weeks post-initiation of study for participants was computed as \[(Baseline QoL - 16-week QoL)/Baseline QoL\] × 100\]. Positive value indicates improvement.
Outcome measures
| Measure |
Drug: Sarilumab
n=8 Participants
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=7 Participants
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Percent Change in Quality of Life (QoL) Using Mastocytosis Symptoms Assessment Form (MSAF)
|
55.83 percentage of change in quality of life
Interval 43.0 to 68.66
|
42.20 percentage of change in quality of life
Interval 28.48 to 55.91
|
Adverse Events
Drug: Sarilumab
Placebo
Serious adverse events
| Measure |
Drug: Sarilumab
n=8 participants at risk
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=8 participants at risk
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Gastrointestinal disorders
Large intestine perforation
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
Other adverse events
| Measure |
Drug: Sarilumab
n=8 participants at risk
Participants with indolent systemic mastocytosis receive sarilumab 200 mg (1.14 ml) subcutaneous injection every two weeks for 16 weeks (8 doses total)
|
Placebo
n=8 participants at risk
Participants with indolent systemic mastocytosis receive placebo subcutaneous injection every two weeks for 16 week (8 doses total)
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Cardiac disorders
Dizziness
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Pharyngitis
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Adverse reaction
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Injection site bruising
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Injection site erythema
|
37.5%
3/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Injection site induration
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Irritability
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Pain
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
General disorders
Procedural pain
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Infections and infestations
Bacterial vaginosis
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Infections and infestations
Candida infection
|
37.5%
3/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Blood chloride increased
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Blood cholesterol increased
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
37.5%
3/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
37.5%
3/8 • Up to 16 weeks after final dose of intervention
|
37.5%
3/8 • Up to 16 weeks after final dose of intervention
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Nervous system disorders
Insomnia
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
25.0%
2/8 • Up to 16 weeks after final dose of intervention
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Renal and urinary disorders
Genitourinary tract infection
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Reproductive system and breast disorders
Perimenopausal symptoms
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Up to 16 weeks after final dose of intervention
|
0.00%
0/8 • Up to 16 weeks after final dose of intervention
|
|
Vascular disorders
Hypertension
|
62.5%
5/8 • Up to 16 weeks after final dose of intervention
|
62.5%
5/8 • Up to 16 weeks after final dose of intervention
|
Additional Information
Hirsh Komarow
National Institute of Allergy and Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place