TriangleNCT00432094 · OUTCOME
Engraftment of Platelets
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 100
What was measured
Platelet engraftment is defined as 20,000/mm\^3 (20 x 10\^9/L) for 3 consecutive days unsupported by a platelet transfusion.
Analysis population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.
Groups in this outcome
2 Transplants
Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
1 Transplant
Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
| Group | Source count |
|---|---|
| 2 Transplants | 14 |
| 1 Transplant | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 2 Transplants | 13 | Not reported | Not reported | Not reported | Not reported |
| 1 Transplant | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Platelet engraftment is defined as 20,000/mm\^3 (20 x 10\^9/L) for 3 consecutive days unsupported by a platelet transfusion.
- groups
- description
- Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
- id
- OG000
- title
- 2 Transplants
- description
- Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
- id
- OG001
- title
- 1 Transplant
- param Type
- NUMBER
- population Description
- The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.
- reporting Status
- POSTED
- time Frame
- Day 100
- title
- Engraftment of Platelets
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice