TriangleNCT03158688 · OUTCOME
Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Randomization to Months 3, 6, 12, and 18
What was measured
Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) 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
3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 90.0 | Not reported | 83.7 | 93.9 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 95.3 | Not reported | 92.1 | 97.2 | Not reported |
6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 79.4 | Not reported | 71.6 | 85.3 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 86.4 | Not reported | 81.8 | 89.9 | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 62.7 | Not reported | 53.6 | 70.5 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 77.5 | Not reported | 72.1 | 82.0 | Not reported |
18 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | 45.1 | Not reported | 34.5 | 55.4 | Not reported |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | 68.5 | Not reported | 62.2 | 74.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 83.7
- upper Limit
- 93.9
- value
- 90.0
- group Id
- OG001
- lower Limit
- 92.1
- upper Limit
- 97.2
- value
- 95.3
- title
- 3 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.6
- upper Limit
- 85.3
- value
- 79.4
- group Id
- OG001
- lower Limit
- 81.8
- upper Limit
- 89.9
- value
- 86.4
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.6
- upper Limit
- 70.5
- value
- 62.7
- group Id
- OG001
- lower Limit
- 72.1
- upper Limit
- 82.0
- value
- 77.5
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.5
- upper Limit
- 55.4
- value
- 45.1
- group Id
- OG001
- lower Limit
- 62.2
- upper Limit
- 74.0
- value
- 68.5
- title
- 18 months
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 312
- units
- Participants
- description
- Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) 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
- NUMBER
- population Description
- Intent to Treat Population
- reporting Status
- POSTED
- time Frame
- Randomization to Months 3, 6, 12, and 18
- title
- Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice