TriangleNCT00711828 · OUTCOME
Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- up to 12 cycles (28 days per cycle) of treatment
What was measured
Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.
Groups in this outcome
Treatment
Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
| Group | Source count |
|---|---|
| Treatment | 21 |
Reported measurements
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment | 19 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment | 8 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.
- groups
- description
- Rituximab 375 mg/m2 IV on day 1 \> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 \> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 \> Dexamethasone 40 mg PO on days 1, 8, 15, 22
- id
- OG000
- title
- Treatment
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- up to 12 cycles (28 days per cycle) of treatment
- title
- Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice