TriangleNCT02757326 · OUTCOME
Number of Patients With Dose Limiting Toxicity
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
- 12 months
What was measured
For the phase 1b portion of the trial, a dose-limiting toxicity (DLT) was defined as an adverse event at least possibly related to the study medication: Non-hematologic DLT is defined as any Grade 3 or greater ADR (adverse drug reaction), except symptomatic AEs such as nausea, vomiting, and diarrhea which could be reduced to less than Grade 3 within 72 hours with standard supportive measures (i.e., antiemetics and antidiarrheals). Hematologic DLT is defined as * Grade 4 neutropenia or thrombocytopenia that lasts more than 7 days after the last dose of study drug * or greater than or equal to Grade 3 thrombocytopenia in the presence of greater than or equal to Grade 3 hemorrhage of any organ/site * or any Grade 5 hematologic toxicity
Analysis population: All participants receiving any amount of study drug
Groups in this outcome
ABC294640 250 mg BID
ABC294640 250 mg BID given continuously
ABC294640 500 mg BID
ABC294640 250 mg BID given continuously
ABC294640 750 mg BID
ABC294640 750 mg BID given continuously
| Group | Source count |
|---|---|
| ABC294640 250 mg BID | 3 |
| ABC294640 500 mg BID | 4 |
| ABC294640 750 mg BID | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ABC294640 250 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| ABC294640 500 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| ABC294640 750 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- For the phase 1b portion of the trial, a dose-limiting toxicity (DLT) was defined as an adverse event at least possibly related to the study medication: Non-hematologic DLT is defined as any Grade 3 or greater ADR (adverse drug reaction), except symptomatic AEs such as nausea, vomiting, and diarrhea which could be reduced to less than Grade 3 within 72 hours with standard supportive measures (i.e., antiemetics and antidiarrheals). Hematologic DLT is defined as * Grade 4 neutropenia or thrombocytopenia that lasts more than 7 days after the last dose of study drug * or greater than or equal to Grade 3 thrombocytopenia in the presence of greater than or equal to Grade 3 hemorrhage of any organ/site * or any Grade 5 hematologic toxicity
- groups
- description
- ABC294640 250 mg BID given continuously
- id
- OG000
- title
- ABC294640 250 mg BID
- description
- ABC294640 250 mg BID given continuously
- id
- OG001
- title
- ABC294640 500 mg BID
- description
- ABC294640 750 mg BID given continuously
- id
- OG002
- title
- ABC294640 750 mg BID
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants receiving any amount of study drug
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Number of Patients With Dose Limiting Toxicity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice