TriangleNCT00084838 · OUTCOME
Grade 3/4 Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- adverse events
- Interval / dispersion
- Not reported
- Time frame
- Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
What was measured
All Grade 3-4 events based on CTCAEv2 as reported on case report forms.
Analysis population: The analysis population excludes 1 patient who withdrew before treatment.
Groups in this outcome
Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)
Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
| Group | Source count |
|---|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1021 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1021
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- All Grade 3-4 events based on CTCAEv2 as reported on case report forms.
- groups
- description
- Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
- id
- OG000
- title
- Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)
- param Type
- NUMBER
- population Description
- The analysis population excludes 1 patient who withdrew before treatment.
- reporting Status
- POSTED
- time Frame
- Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
- title
- Grade 3/4 Events
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- adverse events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice