TriangleNCT03512353 · OUTCOME
Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6
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
- Cycles 1 - 6 (each cycle is 28 days)
What was measured
Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.
Analysis population: All enrolled and treated participants
Groups in this outcome
Carfilzomib Plus Dexamethasone
Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
| Group | Source count |
|---|---|
| Carfilzomib Plus Dexamethasone | 6 |
Reported measurements
Any dose modification
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
Due to adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Due to dose administration error
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Per protocol
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Due to weight change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Due to scheduling issues
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib Plus Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Any dose modification
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Due to adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Due to dose administration error
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Per protocol
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Due to weight change
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Due to scheduling issues
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.
- groups
- description
- Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
- id
- OG000
- title
- Carfilzomib Plus Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All enrolled and treated participants
- reporting Status
- POSTED
- time Frame
- Cycles 1 - 6 (each cycle is 28 days)
- title
- Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice