TriangleNCT01985126 · OUTCOME
Duration of Response
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
- Up to 14.4 Months
What was measured
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be \>=0.5 g/dL) and/or; urine M-component (the absolute increase must be \>=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be \>10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter \[mmol/L\]) that can be attributed solely to the plasma cell proliferative disorder.
Analysis population: Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.
Groups in this outcome
Daratumumab 8 mg/kg
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Daratumumab 8 mg/kg | 2 |
| Daratumumab 16 mg/kg | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab 8 mg/kg | NA | Not reported | 1.8 | NA | These were Kaplan-Meier estimates. Median and/or upper limit of CI was not estimable because a small proportion of responders either progressed or died due to progressive disease. |
| Daratumumab 16 mg/kg | 7.4 | Not reported | 5.5 | NA | These were Kaplan-Meier estimates. Median and/or upper limit of CI was not estimable because a small proportion of responders either progressed or died due to progressive disease. |
Complete source fields
- classes
- categories
- measurements
- comment
- These were Kaplan-Meier estimates. Median and/or upper limit of CI was not estimable because a small proportion of responders either progressed or died due to progressive disease.
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- NA
- value
- NA
- comment
- These were Kaplan-Meier estimates. Median and/or upper limit of CI was not estimable because a small proportion of responders either progressed or died due to progressive disease.
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- NA
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be \>=0.5 g/dL) and/or; urine M-component (the absolute increase must be \>=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be \>10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter \[mmol/L\]) that can be attributed solely to the plasma cell proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Daratumumab 8 mg/kg
- description
- Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Daratumumab 16 mg/kg
- param Type
- MEDIAN
- population Description
- Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 14.4 Months
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice