TriangleNCT01179490 · OUTCOME
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Events
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
Groups in this outcome
SyB L-0501 + Prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
| Group | Source count |
|---|---|
| SyB L-0501 + Prednisolone | 5 |
Reported measurements
Adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 166 | Not reported | Not reported | Not reported | Not reported |
Related adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 155 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 4 | Not reported | Not reported | Not reported | Not reported |
Related serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 166
- title
- Adverse events
- categories
- measurements
- group Id
- OG000
- value
- 155
- title
- Related adverse events
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Related serious adverse events
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
- groups
- description
- SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
- id
- OG000
- title
- SyB L-0501 + Prednisolone
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
- type
- SECONDARY
- unit Of Measure
- Events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice