TriangleNCT02399085 · OUTCOME
Duration of Response (DoR) by IRC Evaluation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
What was measured
DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Analysis population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
Groups in this outcome
Treatment (MOR00208, Lenalidomide)
MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
| Group | Source count |
|---|---|
| Treatment (MOR00208, Lenalidomide) | 46 |
Reported measurements
Approximately 4.5 years after first participant enrolled
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | 43.9 | Not reported | 26.1 | NA | \[Not available\]. Upper limit not reached due to insufficient number of events at later stages of follow-up. |
Approximately 6.5 years after first participant enrolled
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | NA | Not reported | 33.8 | NA | \[Not available\]. Median and upper limit not reached due to insufficient number of events at later stages of follow-up. |
Complete source fields
- classes
- categories
- measurements
- comment
- \[Not available\]. Upper limit not reached due to insufficient number of events at later stages of follow-up.
- group Id
- OG000
- lower Limit
- 26.1
- upper Limit
- NA
- value
- 43.9
- title
- Approximately 4.5 years after first participant enrolled
- categories
- measurements
- comment
- \[Not available\]. Median and upper limit not reached due to insufficient number of events at later stages of follow-up.
- group Id
- OG000
- lower Limit
- 33.8
- upper Limit
- NA
- value
- NA
- title
- Approximately 6.5 years after first participant enrolled
- denoms
- counts
- group Id
- OG000
- value
- 46
- units
- Participants
- description
- DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
- id
- OG000
- title
- Treatment (MOR00208, Lenalidomide)
- param Type
- MEDIAN
- population Description
- FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
- reporting Status
- POSTED
- time Frame
- Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
- title
- Duration of Response (DoR) by IRC Evaluation
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice