TriangleNCT02603172 · OUTCOME
Part B: Number of Participants With Abnormal Urinalysis Data by Dipstick
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cohort 3 and 4: Up to Day 3
What was measured
Urine samples were collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.
Analysis population: Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.
Groups in this outcome
Part B: Cohort 3- GSK3039294 600 mg QD
Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
Part B: Cohort 4a- GSK3039294
Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
Part B: Cohort 4b- GSK3039294
Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
| Group | Source count |
|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 8 |
| Part B: Cohort 4a- GSK3039294 | 0 |
| Part B: Cohort 4b- GSK3039294 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Cohort 3- GSK3039294 600 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Urine samples were collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.
- groups
- description
- Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
- id
- OG000
- title
- Part B: Cohort 3- GSK3039294 600 mg QD
- description
- Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
- id
- OG001
- title
- Part B: Cohort 4a- GSK3039294
- description
- Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
- id
- OG002
- title
- Part B: Cohort 4b- GSK3039294
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.
- reporting Status
- POSTED
- time Frame
- Cohort 3 and 4: Up to Day 3
- title
- Part B: Number of Participants With Abnormal Urinalysis Data by Dipstick
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice