Trial Outcomes & Findings for A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children (NCT NCT03292588)

Results Overview

Exacerbations were defined as a prescription of a course of systemic corticosteroids by a clinician, initiation of a course of systemic corticosteroids by a participant, or as a hospitalization for asthma. If a participant initiated and completed a course of systemic corticosteroids without clinician involvement, this course was counted only if the study clinician agreed the treatment was warranted, and it met the following dosage: the course for prednisone, prednisolone, or methylprednisolone was at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone was at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation was prescribed by a non-ICAC clinician, it was counted regardless of dose.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

335 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2022-07-20

Participant Flow

335 people were enrolled in the study (signed a consent and were assigned a unique participant number). However, 45 participants dropped out before receiving treatment bringing the total to 290 participants who started treatment.

Participant milestones

Participant milestones
Measure	Mepolizumab Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Overall Study STARTED	146	144
Overall Study COMPLETED	126	122
Overall Study NOT COMPLETED	20	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Mepolizumab Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Overall Study Death	1	0
Overall Study Lost to Follow-up	12	16
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	4	4
Overall Study Move out of town	1	0
Overall Study >3 bursts of systemic corticosteroids for asthma during treatment period (Starting Nov 2020)	2	1

Baseline Characteristics

A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Total n=290 Participants Total of all reporting groups
Age, Categorical <=18 years	146 Participants n=5 Participants	144 Participants n=7 Participants	290 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 2.87 • n=5 Participants	10.8 years STANDARD_DEVIATION 2.88 • n=7 Participants	10.8 years STANDARD_DEVIATION 2.87 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	55 Participants n=7 Participants	126 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	89 Participants n=7 Participants	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	107 Participants n=7 Participants	218 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
Region of Enrollment United States	146 participants n=5 Participants	144 participants n=7 Participants	290 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: All participants who were randomized and received at least one dose of study treatment

Exacerbations were defined as a prescription of a course of systemic corticosteroids by a clinician, initiation of a course of systemic corticosteroids by a participant, or as a hospitalization for asthma. If a participant initiated and completed a course of systemic corticosteroids without clinician involvement, this course was counted only if the study clinician agreed the treatment was warranted, and it met the following dosage: the course for prednisone, prednisolone, or methylprednisolone was at least 20 mg daily dose for 3 of 5 consecutive days. The course for dexamethasone was at least a 10 mg single daily dose. If a corticosteroid burst for the treatment of an asthma exacerbation was prescribed by a non-ICAC clinician, it was counted regardless of dose.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Number of Asthma Exacerbations During the Treatment Period	0.96 Exacerbations during treatment Standard Error 0.10	1.30 Exacerbations during treatment Standard Error 0.13

SECONDARY outcome

Timeframe: Week 12, 24, 36, 48, 52 after randomization

Population: All participants who were randomized and received at least one dose of study treatment

Composite Asthma Severity Index (CASI) scores included 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The minimum composite score was 0 while the maximum was 20. The higher the score the more allergy symptoms a subject has.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Composite Asthma Severity Index (CASI) Week 12	6.17 Composite Asthma Severity Index Standard Error 0.2	6.45 Composite Asthma Severity Index Standard Error 0.20
Composite Asthma Severity Index (CASI) Week 24	5.94 Composite Asthma Severity Index Standard Error 0.23	6.01 Composite Asthma Severity Index Standard Error 0.23
Composite Asthma Severity Index (CASI) Week 36	5.48 Composite Asthma Severity Index Standard Error 0.22	5.99 Composite Asthma Severity Index Standard Error 0.23
Composite Asthma Severity Index (CASI) Week 48	5.16 Composite Asthma Severity Index Standard Error 0.22	5.23 Composite Asthma Severity Index Standard Error 0.22
Composite Asthma Severity Index (CASI) Week 52	5.03 Composite Asthma Severity Index Standard Error 0.23	5.00 Composite Asthma Severity Index Standard Error 0.23

SECONDARY outcome

Timeframe: Week 56

Population: All participants who were randomized and received at least one dose of study treatment and completed the quality of life questionnaire at visit 14.

The Physician Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the physician to evaluate how the participant's quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.

Outcome measures

Outcome measures
Measure	Mepolizumab n=129 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=122 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Significantly Improved	58 Participants	54 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Moderately Improved	27 Participants	33 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Mildly Improved	22 Participants	17 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - No Change	20 Participants	17 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Mildly Worse	1 Participants	1 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Moderately Worse	0 Participants	0 Participants
Participant Quality of Life Measured Using the Physician Global Assessment Tool Physician Global Assessment Tool - Significantly Worse	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 56

Population: All participants who were randomized and received at least one dose of study treatment and completed the quality of life questionnaire at visit 14.

The Patient Global Assessment Tool was used to assess the quality of life of the subjects during treatment. The questionnaire is one question that asks the participant to evaluate how their quality of life changed over the course of treatment. There are seven possible options ranging from significantly worse to significantly improved.

Outcome measures

Outcome measures
Measure	Mepolizumab n=129 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=124 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Moderately Improved	27 Participants	23 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Mildly Improved	11 Participants	12 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - No Change	7 Participants	2 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Mildly Worse	2 Participants	0 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Moderately Worse	0 Participants	0 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Significantly Worse	0 Participants	0 Participants
Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 Patient Global Assessment Tool - Significantly Improved	82 Participants	87 Participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48, 52 after randomization

Population: All participants who were randomized and received at least one dose of study treatment

A generalized mixed model was used to analyze spirometry parameter at each visit where the lung function was collected. The ratio of the forced expiratory volume to the forced vital capacity of the lungs (FEV1/FVC) is the outcome that measured lung function.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Lung Function as Assessed by Spirometry FEV1/FVC - Week 12	0.747 FEV1/FVC Standard Error 0.007	0.752 FEV1/FVC Standard Error 0.007
Lung Function as Assessed by Spirometry FEV1/FVC - Week 24	0.755 FEV1/FVC Standard Error 0.007	0.766 FEV1/FVC Standard Error 0.007
Lung Function as Assessed by Spirometry FEV1/FVC - Week 36	0.758 FEV1/FVC Standard Error 0.008	0.747 FEV1/FVC Standard Error 0.008
Lung Function as Assessed by Spirometry FEV1/FVC - Week 48	0.755 FEV1/FVC Standard Error 0.008	0.742 FEV1/FVC Standard Error 0.008
Lung Function as Assessed by Spirometry FEV1/FVC - Week 52	0.761 FEV1/FVC Standard Error 0.008	0.763 FEV1/FVC Standard Error 0.008

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48, 52 after randomization

A generalized mixed model was used to analyze impulse oscillometry parameter at each visit where the lung function was collected. The Percent Predicted FEV1 (%) is the outcome that measured lung function.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Lung Function as Assessed by Impulse Oscillometry FEV1PP - Week 12	91.9 Percent Predicted FEV1 (%) Standard Error 1.27	92.3 Percent Predicted FEV1 (%) Standard Error 1.27
Lung Function as Assessed by Impulse Oscillometry FEV1PP - Week 24	90.8 Percent Predicted FEV1 (%) Standard Error 1.46	94.2 Percent Predicted FEV1 (%) Standard Error 1.49
Lung Function as Assessed by Impulse Oscillometry FEV1PP - Week 36	91.5 Percent Predicted FEV1 (%) Standard Error 1.45	89.9 Percent Predicted FEV1 (%) Standard Error 1.46
Lung Function as Assessed by Impulse Oscillometry FEV1PP - Week 48	90.4 Percent Predicted FEV1 (%) Standard Error 1.46	89.8 Percent Predicted FEV1 (%) Standard Error 1.48
Lung Function as Assessed by Impulse Oscillometry FEV1PP - Week 52	90.9 Percent Predicted FEV1 (%) Standard Error 1.45	93.5 Percent Predicted FEV1 (%) Standard Error 1.43

SECONDARY outcome

Timeframe: Up to 12 months

Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE

Outcome measures

Outcome measures
Measure	Mepolizumab n=57 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=51 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Did Not Fit the FDA-approved Dosing Table for Omalizumab Therapy.	1.11 Exacerbations during treatment Standard Error 0.21	1.31 Exacerbations during treatment Standard Error 0.25

SECONDARY outcome

Timeframe: Up to 12 months

Looking at the rate of exacerbations similarly to the primary endpoint. This outcome measure also took into consideration FDA- approved dosing of omalizumab. The FDA-approved dosing table is based off of age, weight and pre-treatment Serum IGE

Outcome measures

Outcome measures
Measure	Mepolizumab n=89 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=93 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Fit the FDA-approved Dosing Table.	0.87 Exacerbations during treatment Standard Error 0.13	1.30 Exacerbations during treatment Standard Error 0.18

SECONDARY outcome

Timeframe: Up to 12 months

Population: All participants who were randomized and received at least one dose of study treatment

A Cox PH model was also used to model the time to first asthma exacerbation during the treatment period. The Cox PH model included treatment arm as the primary exposure but was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (above or below 400 cells/μl), BMI (above or below 95th percentile for age) and total serum IgE (above or below 540 kUA/L).

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Time to First Asthma Exacerbation	241 Days Interval 1.0 to 380.0	224 Days Interval 1.0 to 378.0

SECONDARY outcome

Timeframe: Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)

Population: Number of Subjects with at Least One AE by severity

The number of AEs by severity was used to assess safety. Please refer to the Adverse Event tables for specifics.

Outcome measures

Outcome measures
Measure	Mepolizumab n=113 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=94 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Number of Reported Adverse Events (AEs), Including Their Severity Severity: Grade 1 - Mild	47 Participants	39 Participants
Number of Reported Adverse Events (AEs), Including Their Severity Severity: Grade 2 - Moderate	58 Participants	51 Participants
Number of Reported Adverse Events (AEs), Including Their Severity Severity: Grade 3 - Severe and undesirable	8 Participants	3 Participants
Number of Reported Adverse Events (AEs), Including Their Severity Severity: Grade 4 - Life-threatening or disabling	0 Participants	1 Participants
Number of Reported Adverse Events (AEs), Including Their Severity Severity: Grade 5 - Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)

Population: Number of Subjects with any study procedures related AEs

The number of AEs by relationship to study drug was used to assess safety. Please refer to the Adverse Event tables for specifics.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Number of Reported Adverse Events (AEs), Including Their Treatment Relatedness	46 Participants	26 Participants

SECONDARY outcome

Timeframe: Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)

Population: Number of subjects with Serious Adverse Events

The number of SAEs by severity and relationship to study drug was used to assess safety.

Outcome measures

Outcome measures
Measure	Mepolizumab n=4 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=2 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics. Severity: Grade 2 - Moderate	0 Participants	1 Participants
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics. Severity: Grade 3 - Severe and undesirable	3 Participants	1 Participants
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics. Severity: Grade 4 - Life threatening	0 Participants	0 Participants
Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics. Severity: Grade 5 - Death	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4 (Treatment Initiation) to Week 56 (Completion of Treatment)

Population: Number of subjects with any study procedures related Serious Adverse Events

The number of SAEs by relationship to study drug was used to assess safety.

Outcome measures

Outcome measures
Measure	Mepolizumab n=146 Participants Intervention: Mepolizumab plus guidelines-based standard of care asthma treatment. Mepolizumab: Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.	Placebo n=144 Participants Intervention: Placebo for mepolizumab plus guidelines-based standard of care asthma treatment. Placebo: Placebo administered every 4 weeks by subcutaneous injection at a dose of: * 100 mg for participants ≥12 years of age and * 40 mg for participants ages 6 to 11 years and weighing ≥40 kg. Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg. Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Number of Reported Serious Adverse Events (SAEs) Inclusive of Treatment Relatedness. Please Refer to the Adverse Event Tables for Specifics.	0 Participants	1 Participants

Adverse Events

Mepolizumab

Serious events: 4 serious events

Other events: 53 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mepolizumab n=146 participants at risk Mepolizumab (anti-IL-5 antagonist monoclonal antibody) by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg	Placebo n=144 participants at risk Placebo by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
General disorders All-Cause Mortality	0.00% 0/146 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.00% 0/144 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Cardiac disorders Cardio-respiratory arrest	0.68% 1/146 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.00% 0/144 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Cardiac disorders Tachycardia	0.00% 0/146 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.69% 1/144 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Gastrointestinal disorders Abdominal pain	0.68% 1/146 • Number of events 2 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.00% 0/144 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
General disorders Chest pain	0.00% 0/146 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.69% 1/144 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Psychiatric disorders Major depression	0.68% 1/146 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.00% 0/144 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Psychiatric disorders Suicidal ideation	0.68% 1/146 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.69% 1/144 • Number of events 1 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample

Other adverse events

Other adverse events
Measure	Mepolizumab n=146 participants at risk Mepolizumab (anti-IL-5 antagonist monoclonal antibody) by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg	Placebo n=144 participants at risk Placebo by subcutaneous injection every 4 weeks at the following doses: Age 12 years and above-100 mg, Age 6-11 years-40mg, Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in Protocol ICAC-30 under the previous versions of the protocol and initially assigned a 100 mg dose will have their dose reduced to 40 mg
Gastrointestinal disorders Vomiting	8.9% 13/146 • Number of events 15 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	8.3% 12/144 • Number of events 13 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
General disorders Injection site reaction	8.9% 13/146 • Number of events 14 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	0.00% 0/144 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Infections and infestations Influenza	7.5% 11/146 • Number of events 11 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	7.6% 11/144 • Number of events 11 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Infections and infestations Pharyngitis streptococcal	4.8% 7/146 • Number of events 7 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	6.2% 9/144 • Number of events 9 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Nervous system disorders Headache	10.3% 15/146 • Number of events 19 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	4.9% 7/144 • Number of events 9 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample
Respiratory, thoracic and mediastinal disorders Epistaxis	5.5% 8/146 • Number of events 8 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample	5.6% 8/144 • Number of events 14 • Adverse events were collected from the time of consent until 1 year and the participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study. The safety population was used for reporting adverse events, which was defined as: participants who were randomized and received at least one dose of study treatment. Participants were analyzed according to the medication they actually received, regardless of the treatment arm to which they were randomized. Non-treatment emergent adverse events were summarized in all participants who were enrolled, while treatment emergent adverse events were summarized in the safety sample

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place