NCT00006436 · OUTCOME
Number of Cycles of Hematologic Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- cycles
- Interval / dispersion
- Not reported
- Time frame
- Up to 112 cycles (each cycle is 21 days + 7 days window)
What was measured
Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0).
Analysis population: One participant declined to participate before treatment started.
Groups in this outcome
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
| Group | Source count |
|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 67 |
Reported measurements
Febrile neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 25 | Not reported | Not reported | Not reported | Not reported |
Neutropenia with a Nadir <500 cells/mm^3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 112 | Not reported | Not reported | Not reported | Not reported |
Neutropenia with a Nadir <100 cells/mm^3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 77 | Not reported | Not reported | Not reported | Not reported |
Thrombocytopenia with a Nadir <50,000 platelets/mm^3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 40 | Not reported | Not reported | Not reported | Not reported |
Thrombocytopenia with a Nadir <25,000 platelets/mm^3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 6 | Not reported | Not reported | Not reported | Not reported |
Anemia: hemoglobin <8 g/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1-Combination Chemo and Biological Therapy | 36 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- Febrile neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 112
- title
- Neutropenia with a Nadir <500 cells/mm^3
- categories
- measurements
- group Id
- OG000
- value
- 77
- title
- Neutropenia with a Nadir <100 cells/mm^3
- categories
- measurements
- group Id
- OG000
- value
- 40
- title
- Thrombocytopenia with a Nadir <50,000 platelets/mm^3
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Thrombocytopenia with a Nadir <25,000 platelets/mm^3
- categories
- measurements
- group Id
- OG000
- value
- 36
- title
- Anemia: hemoglobin <8 g/dL
- denoms
- counts
- group Id
- OG000
- value
- 67
- units
- Participants
- description
- Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0).
- groups
- description
- Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- id
- OG000
- title
- Arm 1-Combination Chemo and Biological Therapy
- param Type
- NUMBER
- population Description
- One participant declined to participate before treatment started.
- reporting Status
- POSTED
- time Frame
- Up to 112 cycles (each cycle is 21 days + 7 days window)
- title
- Number of Cycles of Hematologic Toxicity
- type
- SECONDARY
- unit Of Measure
- cycles
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle