TriangleNCT03158688 · OUTCOME
Kaplan-Meier Estimate for Time to Next Treatment (TTNT)
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
- PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
What was measured
Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Analysis population: Intent to Treat Population
Groups in this outcome
Kd - Carfilzomib and Dexamethasone
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
KdD - Carfilzomib, Dexamethasone and Daratumumab
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
| Group | Source count |
|---|---|
| Kd - Carfilzomib and Dexamethasone | 154 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 312 |
Reported measurements
PA DCO
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 17.3 | Not reported | 13.5 | NA | Not enough events to estimate the upper 95% CI |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | NA | Not reported | NA | NA | Not enough events to estimate a median and confidence intervals |
FA DCO
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 17.8 | Not reported | 13.5 | 23.1 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 37.4 | Not reported | 30.1 | 47.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Not enough events to estimate the upper 95% CI
- group Id
- OG000
- lower Limit
- 13.5
- upper Limit
- NA
- value
- 17.3
- comment
- Not enough events to estimate a median and confidence intervals
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- PA DCO
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.5
- upper Limit
- 23.1
- value
- 17.8
- group Id
- OG001
- lower Limit
- 30.1
- upper Limit
- 47.8
- value
- 37.4
- title
- FA DCO
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 312
- units
- Participants
- description
- Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
- id
- OG000
- title
- Kd - Carfilzomib and Dexamethasone
- description
- Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
- id
- OG001
- title
- KdD - Carfilzomib, Dexamethasone and Daratumumab
- param Type
- MEDIAN
- population Description
- Intent to Treat Population
- reporting Status
- POSTED
- time Frame
- PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
- title
- Kaplan-Meier Estimate for Time to Next Treatment (TTNT)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice