TriangleNCT01415882 · OUTCOME
Overall Survival
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
- 2.5 years
What was measured
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Analysis population: All eligible patients that started treatment.
Groups in this outcome
Arm A (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Ixazomib Citrate and Dexamethasone) | 32 |
| Arm B (Ixazomib Citrate and Dexamethasone) | 35 |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | 35 |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | 33 |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Ixazomib Citrate and Dexamethasone) | NA | Not reported | NA | NA | Not enough events occurred to calculate the Median or confidence intervals |
| Arm B (Ixazomib Citrate and Dexamethasone) | NA | Not reported | 26.3 | NA | Not enough events occurred to calculate the Median or upper confidence interval |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | NA | Not reported | 25.5 | NA | Not enough events occurred to calculate the Median or upper confidence interval |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | NA | Not reported | NA | NA | Not enough events occurred to calculate the Median or confidence intervals |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | NA | Not reported | NA | NA | Not enough events occurred to calculate the Median or confidence intervals |
Complete source fields
- classes
- categories
- measurements
- comment
- Not enough events occurred to calculate the Median or confidence intervals
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not enough events occurred to calculate the Median or upper confidence interval
- group Id
- OG001
- lower Limit
- 26.3
- upper Limit
- NA
- value
- NA
- comment
- Not enough events occurred to calculate the Median or upper confidence interval
- group Id
- OG002
- lower Limit
- 25.5
- upper Limit
- NA
- value
- NA
- comment
- Not enough events occurred to calculate the Median or confidence intervals
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not enough events occurred to calculate the Median or confidence intervals
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 24
- units
- Participants
- description
- The distribution of survival time will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
- param Type
- MEDIAN
- population Description
- All eligible patients that started treatment.
- reporting Status
- POSTED
- time Frame
- 2.5 years
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice