NCT02064387 · OUTCOME
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Grams per day
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Day 1 (Cycle 2, 3, 4, 5, 6)
What was measured
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Analysis population: Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Groups in this outcome
Part 1: GSK2857916 0.96 mg/kg
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 3 |
|---|
Reported measurements
Day 1 (Cycle 2), n=2
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 2 |
|---|
Values in Grams per day · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 0.2 | 0.35 | Not reported | Not reported | Not reported |
|---|
Day 1 (Cycle 3), n=2
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 2 |
|---|
Values in Grams per day · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK2857916 0.96 mg/kg | -0.1 | 0.07 | Not reported | Not reported | Not reported |
|---|
Day 1 (Cycle 4), n=1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 1 |
|---|
Values in Grams per day · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK2857916 0.96 mg/kg | -0.1 | NA | Not reported | Not reported | NA indicates that standard deviation could not be calculated for a single participant |
|---|
Day 1 (Cycle 5), n=1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 1 |
|---|
Values in Grams per day · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 0.0 | NA | Not reported | Not reported | NA indicates that standard deviation could not be calculated for a single participant |
|---|
Day 1 (Cycle 6), n=1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 1 |
|---|
Values in Grams per day · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK2857916 0.96 mg/kg | 0.2 | NA | Not reported | Not reported | NA indicates that standard deviation could not be calculated for a single participant |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- 0.2
- title
- Day 1 (Cycle 2), n=2
- categories
- measurements
- group Id
- OG000
- spread
- 0.07
- value
- -0.1
- title
- Day 1 (Cycle 3), n=2
- categories
- measurements
- comment
- NA indicates that standard deviation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- -0.1
- title
- Day 1 (Cycle 4), n=1
- categories
- measurements
- comment
- NA indicates that standard deviation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 0.0
- title
- Day 1 (Cycle 5), n=1
- categories
- measurements
- comment
- NA indicates that standard deviation could not be calculated for a single participant
- group Id
- OG000
- spread
- NA
- value
- 0.2
- title
- Day 1 (Cycle 6), n=1
- description
- Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG000
- title
- Part 1: GSK2857916 0.96 mg/kg
- param Type
- MEAN
- population Description
- Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
- reporting Status
- POSTED
- time Frame
- Baseline and Day 1 (Cycle 2, 3, 4, 5, 6)
- title
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg
- type
- PRIMARY
- unit Of Measure
- Grams per day
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