TriangleNCT02603172 · OUTCOME
Part A: 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
- Day 1
What was measured
Urine samples were collected and urinalysis included analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.
Analysis population: Safety population
Groups in this outcome
Part A: GSK3039294 200 mg
Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
Part A: GSK3039294 600 mg
Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
Part A: GSK3039294 1200 mg
Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
| Group | Source count |
|---|---|
| Part A: GSK3039294 200 mg | 8 |
| Part A: GSK3039294 600 mg | 16 |
| Part A: GSK3039294 1200 mg | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: GSK3039294 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: GSK3039294 600 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: GSK3039294 1200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- Urine samples were collected and urinalysis included analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.
- groups
- description
- Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
- id
- OG000
- title
- Part A: GSK3039294 200 mg
- description
- Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
- id
- OG001
- title
- Part A: GSK3039294 600 mg
- description
- Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
- id
- OG002
- title
- Part A: GSK3039294 1200 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1
- title
- Part A: 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