Trial · NCT03126227
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment.~Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events.~None of the subjects in Placebo group discontinued dosing due to chronic/recurrent gastrointestinal adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | number of events | NUMBER |
| SECONDARY | Frequency of Anaphylaxis as Defined in the Protocol | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Epinephrine Use as Rescue Medication | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 4-11 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Change in ACT total score from baseline | MEAN |
| SECONDARY | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 12-17 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Change in ACT total score from baseline | MEAN |
| SECONDARY | Frequency of Adverse Events That Led to Early Withdrawal | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03126227/outcomes