TriangleNCT01415882 · OUTCOME
Incidence of Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage or patients
- Interval / dispersion
- Not reported
- Time frame
- 2.5 years
What was measured
Graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The maximum grade for each type of adverse event, regardless of causality, will be recorded. The percentage of patients that experience a grade 3 or higher adverse event will be reported by arm.
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) | 33 |
| Arm B (Ixazomib Citrate and Dexamethasone) | 35 |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | 35 |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | 36 |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Ixazomib Citrate and Dexamethasone) | 79 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Ixazomib Citrate and Dexamethasone) | 49 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | 74 | Not reported | Not reported | Not reported | Not reported |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | 83 | Not reported | Not reported | Not reported | Not reported |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | 96 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 74
- group Id
- OG003
- value
- 83
- group Id
- OG004
- value
- 96
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 36
- group Id
- OG004
- value
- 24
- units
- Participants
- description
- Graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The maximum grade for each type of adverse event, regardless of causality, will be recorded. The percentage of patients that experience a grade 3 or higher adverse event will be reported by arm.
- 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
- NUMBER
- reporting Status
- POSTED
- time Frame
- 2.5 years
- title
- Incidence of Adverse Events
- type
- SECONDARY
- unit Of Measure
- percentage or patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice