TriangleNCT01864018 · OUTCOME
Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
What was measured
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Groups in this outcome
Phase I/II, Cohort A
Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Phase I/II, Cohort A | 48 |
| Phase II, Cohort B | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I/II, Cohort A | 36 | Not reported | Not reported | Not reported | Not reported |
| Phase II, Cohort B | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
- groups
- description
- Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Phase I/II, Cohort A
- description
- Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Phase II, Cohort B
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice