Trial · NCT01831804
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population comprised of all participants who received at least one dose of study drug (including GSK1278863, placebo and standard care). | Participants | NUMBER |
| PRIMARY | Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A) | Day 1 (pre-dose and 48 hours) of Periods 1 and 2 | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B) | Days 1 and 7 (pre-dose), Day 14 (24 hours) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Nurse/Physician Observation (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | ||
| PRIMARY | Number of Participants With Abnormal Nurse/Physician Observation (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | ||
| PRIMARY | Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A) | Day 1 (pre-dose) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B) | Day 1 (pre-dose) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part A) | Day 1 (pre-dose and 48 hours) in period 1; Day 1 (48 hours) in period 2 | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part B) | Days 1 and 7 (pre-dose) and Day 14 (24 hours) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Maximum Observed Concentration (Cmax) of GSK1278863 (Part A) | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose | All participants from whom a PK sample had been obtained and analyzed were included in the PK Population | Nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Cmax of GSK1278863 (Part B) | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | PK Population | ng/mL | MEAN |
| PRIMARY | Time of Occurrence of Cmax (Tmax) of GSK1278863 (Part A) | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | PK population | Hour | MEAN |
| PRIMARY | Tmax of GSK1278863 (Part B) | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | PK Population | Hour | MEAN |
| PRIMARY | Apparent Terminal Elimination Half-life (t1/2) of GSK1278863 (Part A) | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | PK Population | Hour | MEAN |
| PRIMARY | t1/2 of GSK1278863 (Part B) | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | PK Population | Hour | MEAN |
| PRIMARY | Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part A) | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | PK Population | Hour | MEAN |
| PRIMARY | Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part B) | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | PK Population | Hour | MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT01831804/outcomes