Trial · NCT02819557
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Baseline up to Week 56 | All participants who received at least 1 dose of ataluren (Safety Population). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinically Meaningful Abnormal Clinical Laboratory (Biochemistry, Hematology, and Urinalysis) Parameter | Baseline up to Week 56 | All participants who received at least 1 dose of ataluren (Safety Population). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Results | Baseline up to Week 56 | All participants who received at least 1 dose of ataluren (Safety Population). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Dose-Limiting Toxicity as Measured by Hepatic and Renal Toxicity | Baseline up to Week 56 | All participants who received at least 1 dose of ataluren (Safety Population). | participants | NUMBER |
| SECONDARY | Pharmacokinetics: Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Cmax0-6hr) | 0 (predose), 1, 2, 4, and 6 (postdose) hours on Days 1 and 28 | All participants who received at least 1 dose of ataluren and had at least 1 PK concentration datum (PK Population). | microgram/milliliter (µg/mL) | MEAN |
| SECONDARY | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Tmax0-6hr) | 0 (predose), 1, 2, 4, and 6 (postdose) hours on Days 1 and 28 | All participants who received at least 1 dose of ataluren and had at least 1 PK concentration datum (PK Population). | hours | MEAN |
| SECONDARY | Area Under the Plasma Concentration Time Curve From Time Zero up to 10 Hours After the Morning Dose (AUC0-10hr) | 0 (predose), 1, 2, 4, 6, 8, and 10 (postdose) hours on Days 1 and 28 | All participants who received at least 1 dose of ataluren and had at least 1 PK concentration datum (PK Population). | hour*μg/mL | MEAN |
| SECONDARY | Pharmacokinetics: Concentration at the End of the First (Morning) Dose Interval (Ctrough6hr) | 0 (predose), 1, 2, 4, and 6 (postdose) hours on Days 1 and 28 | All participants who received at least 1 dose of ataluren and had at least 1 PK concentration datum (PK Population). | microgram per milliliter (µg/ml) | MEAN |
| SECONDARY | Change From Baseline in Proximal Muscle Function as Assessed by Speed During TFTs | Baseline, Week 28 and Week 52 | All participants who received at least 1 dose of ataluren and had a baseline and at least 1 postbaseline measurement for TFT, NSAA, or response to the palatability of ataluren questions (Evaluable Population) and had evaluable data for the applicable timed function test. | seconds | MEAN |
| SECONDARY | Change From Baseline in Physical Function as Measured by the NSAA | Baseline, Week 28 and Week 52 | All participants who received at least 1 dose of ataluren and had a baseline and at least 1 postbaseline measurement for TFT, NSAA, or response to the palatability of ataluren questions (Evaluable Population) and had evaluable NSAA data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Height of Participants at Weeks 4, 16, 28, 40, 52, and 56 | Baseline, Weeks 4, 16, 28, 40, 52, and 56 | All participants who received at least 1 dose of ataluren (Safety Population) and had evaluable height data. | centimeters | MEAN |
| SECONDARY | Change From Baseline in Weight of Participants at Weeks 4, 16, 28, 40, 52, and 56 | Baseline, Weeks 4, 16, 28, 40, 52, and 56 | All participants who received at least 1 dose of ataluren (Safety Population) and had evaluable weight data. | kg | MEAN |
| SECONDARY | Change From Baseline in Body Mass Index of Participants at Weeks 4, 16, 28, 40, 52, and 56 | Baseline, Weeks 4, 16, 28, 40, 52, and 56 | All participants who received at least 1 dose of ataluren (Safety Population). | kilograms per square meter (kg/m^2) | MEAN |
| SECONDARY | Ataluren Palatability Characteristics as Determined by a Parent/Caregiver Questionnaire | Baseline up to Week 28 | All participants who received at least 1 dose of ataluren and had a baseline and at least 1 postbaseline measurement for TFT, NSAA, or response to the palatability of ataluren questions (Evaluable Population). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT02819557/outcomes