TriangleNCT00369317 · OUTCOME
Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of participants
- Interval / dispersion
- Not reported
- Time frame
- From the beginning of induction therapy to the end of intensification therapy
What was measured
Proportion of participants with at least one grade 3 or higher adverse event during therapy.
Analysis population: Ineligible patients (n=1) are excluded.
Groups in this outcome
Treatment (Combination Chemotherapy)
INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Combination Chemotherapy) | 204 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Combination Chemotherapy) | 0.911765 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.911765
- denoms
- counts
- group Id
- OG000
- value
- 204
- units
- Participants
- description
- Proportion of participants with at least one grade 3 or higher adverse event during therapy.
- groups
- description
- INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Treatment (Combination Chemotherapy)
- param Type
- NUMBER
- population Description
- Ineligible patients (n=1) are excluded.
- reporting Status
- POSTED
- time Frame
- From the beginning of induction therapy to the end of intensification therapy
- title
- Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
- type
- SECONDARY
- unit Of Measure
- Proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice