Trial · NCT02819557
Results by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 78
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | At least 1 TEAE | 14 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | Mild TEAE | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | Moderate TEAE | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | Severe TEAE | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | TEAE Related to Study Drug | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | TEAE Leading to Participant Study Discontinuation | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) | Ataluren | Serious TEAE | 0 | Participants | |
| Number of Participants With a Clinically Meaningful Abnormal Clinical Laboratory (Biochemistry, Hematology, and Urinalysis) Parameter | Ataluren | 0 | Participants | ||
| Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Results | Ataluren | 0 | Participants | ||
| Number of Participants With a Dose-Limiting Toxicity as Measured by Hepatic and Renal Toxicity | Ataluren | 0 | participants | ||
| Pharmacokinetics: Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Cmax0-6hr) | Ataluren | Day 1 | 15.95 | Standard Deviation 9.51 | microgram/milliliter (µg/mL) |
| Pharmacokinetics: Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Cmax0-6hr) | Ataluren | Day 28 | 12.54 | Standard Deviation 4.43 | microgram/milliliter (µg/mL) |
| Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Tmax0-6hr) | Ataluren | Day 1 | 3.84 | Standard Deviation 1.82 | hours |
| Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration From Time Zero up to 6 Hours After the Morning Dose (Tmax0-6hr) | Ataluren | Day 28 | 2.72 | Standard Deviation 1.98 | hours |
| Area Under the Plasma Concentration Time Curve From Time Zero up to 10 Hours After the Morning Dose (AUC0-10hr) | Ataluren | Day 1 | 101.64 | Standard Deviation 58.52 | hour*μg/mL |
| Area Under the Plasma Concentration Time Curve From Time Zero up to 10 Hours After the Morning Dose (AUC0-10hr) | Ataluren | Day 28 | 82.13 | Standard Deviation 27.43 | hour*μg/mL |
| Pharmacokinetics: Concentration at the End of the First (Morning) Dose Interval (Ctrough6hr) | Ataluren | Day 1 | 9.12 | Standard Deviation 8.88 | microgram per milliliter (µg/ml) |
| Pharmacokinetics: Concentration at the End of the First (Morning) Dose Interval (Ctrough6hr) | Ataluren | Day 28 | 5.43 | Standard Deviation 3.15 | microgram per milliliter (µg/ml) |
| Change From Baseline in Proximal Muscle Function as Assessed by Speed During TFTs | Ataluren | Rise to Standing, Baseline | 7.2 | Standard Deviation 7.21 | seconds |
| Change From Baseline in Proximal Muscle Function as Assessed by Speed During TFTs | Ataluren | Rise to Standing, Change from Baseline at Week 28 | -3.1 | Standard Deviation 6.47 | seconds |
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/results