TriangleNCT01556438 · OUTCOME
Time to Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Baseline to date of Progressive Disease (up to 455 days)
What was measured
TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment.
Analysis population: All participants who received at least 1 dose of study drug and didn't have AEs . 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. Participants that were censored prior to PD and not included in analysis:100 mg tabalumab n=4, 300 mg tabalumab n=8.
Groups in this outcome
100 mg Tabalumab+BTZ IV+Dex
Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
300 mg Tabalumab+BTZ +Dex
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab+BTZ +Dex | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | NA | Not reported | NA | NA | No data collected due to censoring prior to PD. |
| 300 mg Tabalumab+BTZ +Dex | NA | Not reported | 0.49 | 8 | Due to censoring prior to PD, median not collected as per Statistical Analysis Plan. |
Complete source fields
- classes
- categories
- measurements
- comment
- No data collected due to censoring prior to PD.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Due to censoring prior to PD, median not collected as per Statistical Analysis Plan.
- group Id
- OG001
- lower Limit
- 0.49
- upper Limit
- 8
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment.
- dispersion Type
- Full Range
- groups
- description
- Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
- id
- OG000
- title
- 100 mg Tabalumab+BTZ IV+Dex
- description
- Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
- id
- OG001
- title
- 300 mg Tabalumab+BTZ +Dex
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose of study drug and didn't have AEs . 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. Participants that were censored prior to PD and not included in analysis:100 mg tabalumab n=4, 300 mg tabalumab n=8.
- reporting Status
- POSTED
- time Frame
- Baseline to date of Progressive Disease (up to 455 days)
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice