TriangleNCT01849783 · OUTCOME
Percentage of Participants With Serious Treatment-Related Complications
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
- From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
What was measured
Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Analysis population: Participants who have had at least one day of protocol treatment
Groups in this outcome
Autologous Stem Cell Transplant
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
| Group | Source count |
|---|---|
| Autologous Stem Cell Transplant | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Autologous Stem Cell Transplant | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
- groups
- description
- Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
- id
- OG000
- title
- Autologous Stem Cell Transplant
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who have had at least one day of protocol treatment
- reporting Status
- POSTED
- time Frame
- From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
- title
- Percentage of Participants With Serious Treatment-Related Complications
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice