NCT02220985 · 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
- Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
- Other-event reporting threshold
- 5%
Only grades 3-5 non-hematologic adverse events were captured.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 21 / 21 | 6 / 21 | 5 / 21 |
| Arm B (MRD / Low Intensity Conditioning) | 17 / 20 | 8 / 20 | 4 / 20 |
| Arm C (MUD / High Intensity Conditioning) | 18 / 18 | 6 / 18 | 4 / 18 |
| Arm D (MUD / Low Intensity Conditioning) | 15 / 18 | 8 / 18 | 4 / 18 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Esophagitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Gastrointestinal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Gastroparesis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 21
- num Events
- 17
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 20
- num Events
- 4
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 18
- num Events
- 18
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 18
- num Events
- 8
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 21
- num Events
- 3
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 20
- num Events
- 5
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 18
- num Events
- 5
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Typhlitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Pain
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 20
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Cytokine release syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Infections and infestations, other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- term
- Hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hypermagnesemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Hypokalemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hypophosphatemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Syncope
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- term
- Hypertension
Complete source fields
- description
- Only grades 3-5 non-hematologic adverse events were captured.
- event Groups
- deaths Num Affected
- 5
- deaths Num At Risk
- 21
- description
- HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- id
- EG000
- other Num Affected
- 6
- other Num At Risk
- 21
- serious Num Affected
- 21
- serious Num At Risk
- 21
- title
- Arm A (MRD / High Intensity Conditioning)
- deaths Num Affected
- 4
- deaths Num At Risk
- 20
- description
- LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
- id
- EG001
- other Num Affected
- 8
- other Num At Risk
- 20
- serious Num Affected
- 17
- serious Num At Risk
- 20
- title
- Arm B (MRD / Low Intensity Conditioning)
- deaths Num Affected
- 4
- deaths Num At Risk
- 18
- description
- HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- id
- EG002
- other Num Affected
- 6
- other Num At Risk
- 18
- serious Num Affected
- 18
- serious Num At Risk
- 18
- title
- Arm C (MUD / High Intensity Conditioning)
- deaths Num Affected
- 4
- deaths Num At Risk
- 18
- description
- LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
- id
- EG003
- other Num Affected
- 8
- other Num At Risk
- 18
- serious Num Affected
- 15
- serious Num At Risk
- 18
- title
- Arm D (MUD / Low Intensity Conditioning)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 20
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Cytokine release syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Infections and infestations, other
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- term
- Hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hypermagnesemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- term
- Hypokalemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Hypophosphatemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 2
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Syncope
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- term
- Hypertension
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 20
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Esophagitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Gastrointestinal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- term
- Gastroparesis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 21
- num Events
- 17
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 20
- num Events
- 4
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 18
- num Events
- 18
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 18
- num Events
- 8
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 21
- num Events
- 3
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 20
- num Events
- 5
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 18
- num Events
- 5
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Typhlitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 18
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 20
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE v4
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 20
- num Events
- 1
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 18
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 18
- num Events
- 0
- term
- Pain
- time Frame
- Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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