TriangleNCT01556438 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- months
- Interval / dispersion
- Not reported
- Time frame
- Time from Response until measured Progressive Disease (up to 455 days)
What was measured
DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date.
Analysis population: All participants who received at least 1 dose of study drug, 4 participants were censored from Cohort 1 and 5 participants from Cohort 2. 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
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 IV or SC.
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab+BTZ +Dex | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | NA | Not reported | Not reported | Not reported | Data is not available to be presented because endpoint was not reached. |
| 300 mg Tabalumab+BTZ +Dex | NA | Not reported | Not reported | Not reported | Data is not available to be presented because endpoint was not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data is not available to be presented because endpoint was not reached.
- group Id
- OG000
- value
- NA
- comment
- Data is not available to be presented because endpoint was not reached.
- group Id
- OG001
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date.
- 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 IV or SC.
- id
- OG001
- title
- 300 mg Tabalumab+BTZ +Dex
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of study drug, 4 participants were censored from Cohort 1 and 5 participants from Cohort 2. 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
- reporting Status
- POSTED
- time Frame
- Time from Response until measured Progressive Disease (up to 455 days)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice