TriangleNCT03525678 · OUTCOME
Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to 186 weeks
What was measured
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Analysis population: Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.
Groups in this outcome
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 32 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 32 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 12.4 | Not reported | 4.2 | 21.4 | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 12.6 | Not reported | 5.6 | 22.8 | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 5.3 | Not reported | 2.8 | 9.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 21.4
- value
- 12.4
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 22.8
- value
- 12.6
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 9.0
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 13
- units
- Participants
- description
- DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG000
- title
- Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG001
- title
- Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
- description
- Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
- id
- OG002
- title
- Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
- param Type
- MEDIAN
- population Description
- Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 186 weeks
- title
- Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice