TriangleNCT02047253 · OUTCOME
Assessment of Toxicities
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
- Baseline through 36 months
What was measured
Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline. On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment
Analysis population: All serious adverse events and \> grade 3 toxicities were reported for patients who received treatment with Carfilzomib
Groups in this outcome
Carfilzomib
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
| Group | Source count |
|---|---|
| Carfilzomib | 28 |
Reported measurements
Anemia (>= Grade 3 or 4)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib | 3 | Not reported | Not reported | Not reported | Not reported |
Hypertension (>= Grade 3 or 4)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Anemia (>= Grade 3 or 4)
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Hypertension (>= Grade 3 or 4)
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- description
- Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline. On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment
- groups
- description
- Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
- id
- OG000
- title
- Carfilzomib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All serious adverse events and \> grade 3 toxicities were reported for patients who received treatment with Carfilzomib
- reporting Status
- POSTED
- time Frame
- Baseline through 36 months
- title
- Assessment of Toxicities
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice