NCT02593123 · ADVERSE EVENTS

Adverse events

Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis · Source last updated 2023-01-23

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 assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (MMF-15, Sargramostim) Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.	15 / 15	15 / 15	4 / 15
Arm II (MMF-30, Filgrastim) Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.	11 / 11	10 / 11	6 / 11

Group identifiers: EG000: Arm I (MMF-15, Sargramostim) · EG001: Arm II (MMF-30, Filgrastim)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
num Events
3
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Catheter Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
cardiac disorders, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
surgical and medical procedures, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Alanine Aminotransferase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Anal Fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Colitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
15
num Events
12
group Id
EG001
num Affected
4
num At Risk
11
num Events
7
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
15
num Events
9
group Id
EG001
num Affected
5
num At Risk
11
num Events
5
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
15
num Events
12
group Id
EG001
num Affected
5
num At Risk
11
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Nausea
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
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Hypernatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
15
num Events
5
group Id
EG001
num Affected
5
num At Risk
11
num Events
6
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
CD4 Lymphocytes Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
3
num At Risk
11
num Events
4
term
White Blood Cell Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Atrial Fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Dyspnea

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
15
description
Patients receive mycophenolate mofetil (MMF) PO or IV BID on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Sargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment. Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis. Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.
id
EG000
other Num Affected
15
other Num At Risk
15
serious Num Affected
15
serious Num At Risk
15
title
Arm I (MMF-15, Sargramostim)
deaths Num Affected
6
deaths Num At Risk
11
description
Patients receive mycophenolate mofetil PO or IV BID on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment. mycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration. Filgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
id
EG001
other Num Affected
10
other Num At Risk
11
serious Num Affected
11
serious Num At Risk
11
title
Arm II (MMF-30, Filgrastim)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
15
num Events
12
group Id
EG001
num Affected
4
num At Risk
11
num Events
7
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
15
num Events
9
group Id
EG001
num Affected
5
num At Risk
11
num Events
5
term
neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
15
num Events
12
group Id
EG001
num Affected
5
num At Risk
11
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Nausea
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
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Hypernatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
15
num Events
5
group Id
EG001
num Affected
5
num At Risk
11
num Events
6
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
CD4 Lymphocytes Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
3
num At Risk
11
num Events
4
term
White Blood Cell Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Atrial Fibrilation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Dyspnea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
15
num Events
2
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
15
num Events
3
group Id
EG001
num Affected
2
num At Risk
11
num Events
2
term
Catheter Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
cardiac disorders, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
surgical and medical procedures, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Alanine Aminotransferase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
15
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Anal Fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
15
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Colitis

time Frame

All Cause Mortality assessed for 2 years. Serious Adverse Events (SAE's) and Adverse Events (AE's) (Other, not included serious) assessed for 6 months.

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