TriangleNCT03159702 · OUTCOME
Serious Adverse Events (SAE).
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
- 2 Years
What was measured
An SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.
Groups in this outcome
MEL/FLU and Total-Body Irradiation (TBI)
For patients who are \< 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1. Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3 Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2 Total Body Irradiation: 200 cGy on Day: -1 Haploidentical Hematopoietic Cell Transplantation: This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.
| Group | Source count |
|---|---|
| MEL/FLU and Total-Body Irradiation (TBI) | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEL/FLU and Total-Body Irradiation (TBI) | 12 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- description
- An SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.
- groups
- description
- For patients who are \< 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1. Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3 Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2 Total Body Irradiation: 200 cGy on Day: -1 Haploidentical Hematopoietic Cell Transplantation: This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.
- id
- OG000
- title
- MEL/FLU and Total-Body Irradiation (TBI)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2 Years
- title
- Serious Adverse Events (SAE).
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice