Trial · NCT01943851
Outcomes62
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 62
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD) | Up to 86.9 weeks | All Treated Population consists of all participants that received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 3 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Reductions | Up to 86.9 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Any Dose Interruptions or Delays | Up to 86.9 weeks | All Treated Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature | Up to 86.9 weeks | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Up to 86.9 weeks | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading) | Up to 86.9 weeks | All Treated Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Objective Response Rate (ORR) (MDS Cohort) | Up to 36.4 weeks | All Treated Population | Percentage of participants | NUMBER |
| PRIMARY | Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts) | Up to 36.4 weeks | All Treated Population. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Overall Response Rate (ORR)- Investigator Assessment | Up to 86.9 weeks | All Treated Population. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single Dose Administration | Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population consisted of all participants in the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat Dose Administration | Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population. Only those participants with data available at the specified data points were analyzed. | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration | Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population. Only those participants with data available at the specified data points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Cmax and Cmin of GSK525762 Following Repeat Dose Administration | Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population. Only those participants with data available at the specified data points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Trough Concentration (Ctau) of GSK525762 Following Repeat Dose Administration | Week 2 Day 7: Pre-dose on Days 4, 6 and 7 | PK Population. Only those participants with data available at the specified data points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Time of Maximum Concentration (Tmax) of GSK525762 Following Single Dose Administration | Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population. Only those participants with data available at the specified data points were analyzed. | Hour | MEDIAN |
| SECONDARY | Part 1: Tmax of GSK525762 Following Repeat Dose Administration | Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose | PK Population. Only those participants with data available at the specified data points were analyzed. | Hour | MEDIAN |
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
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GET https://conductscience.org/api/trials/v1/NCT01943851/outcomes