NCT03096782 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Chemotherapy and Cord Blood Transfusion | 1 / 6 | 6 / 6 | 1 / 6 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Abnormal coagulopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Arm pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- BK cystitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- BK virus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Blurry vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Chest tightness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 6
- term
- Chills
Complete source fields
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 6
- description
- All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10. Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered. GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Cyclophosphamide: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
- id
- EG000
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 1
- serious Num At Risk
- 6
- title
- Chemotherapy and Cord Blood Transfusion
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Abnormal coagulopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Arm pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- BK cystitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- BK virus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Blurry vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Chest tightness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 6
- term
- Chills
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
- time Frame
- All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
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Preserved source evidence · Not medical advice
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