NCT01951885 · ADVERSE EVENTS

Adverse events

Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention · Source last updated 2023-09-11

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: Adverse event data were collected through one year post transplant
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group A (Tacrolimus, Methotrexate) Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.	13 / 50	49 / 50	25 / 50
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil) Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.	3 / 51	47 / 51	15 / 51

Group identifiers: EG000: Group A (Tacrolimus, Methotrexate) · EG001: Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)

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
Renal and urinary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
2
group Id
EG001
num Affected
1
num At Risk
51
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
2
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
50
num Events
4
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Escherichia Coli (E-Coli)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Pulmonary hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Idiopathic pneumonia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
51
num Events
2
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
51
num Events
1
term
Myocardial infarction

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
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
26
num At Risk
50
group Id
EG001
num Affected
24
num At Risk
51
term
abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
41
num At Risk
50
group Id
EG001
num Affected
43
num At Risk
51
term
diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
16
num At Risk
50
group Id
EG001
num Affected
15
num At Risk
51
term
dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
6
num At Risk
50
group Id
EG001
num Affected
3
num At Risk
51
term
encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
14
num At Risk
50
group Id
EG001
num Affected
11
num At Risk
51
term
febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
33
num At Risk
50
group Id
EG001
num Affected
24
num At Risk
51
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
9
num At Risk
50
group Id
EG001
num Affected
9
num At Risk
51
term
hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
22
num At Risk
50
group Id
EG001
num Affected
13
num At Risk
51
term
hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
12
num At Risk
50
group Id
EG001
num Affected
14
num At Risk
51
term
hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
26
num At Risk
50
group Id
EG001
num Affected
33
num At Risk
51
term
hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
51
term
hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
48
num At Risk
50
group Id
EG001
num Affected
44
num At Risk
51
term
nausea

Complete source fields

event Groups

deaths Num Affected
25
deaths Num At Risk
50
description
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11. tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL methotrexate: MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient \< 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
id
EG000
other Num Affected
49
other Num At Risk
50
serious Num Affected
13
serious Num At Risk
50
title
Group A (Tacrolimus, Methotrexate)
deaths Num Affected
15
deaths Num At Risk
51
description
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD). tacrolimus: Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Mycophenolate mofetil: Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol Methotrexate (low dose): MTX 5mg/m2 IV on day +1, +3, +6. If patient\<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
id
EG001
other Num Affected
47
other Num At Risk
51
serious Num Affected
3
serious Num At Risk
51
title
Group B (Tacrolimus, Methotrexate, Mycophenolate Mofetil)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
26
num At Risk
50
group Id
EG001
num Affected
24
num At Risk
51
term
abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
41
num At Risk
50
group Id
EG001
num Affected
43
num At Risk
51
term
diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
16
num At Risk
50
group Id
EG001
num Affected
15
num At Risk
51
term
dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
6
num At Risk
50
group Id
EG001
num Affected
3
num At Risk
51
term
encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
14
num At Risk
50
group Id
EG001
num Affected
11
num At Risk
51
term
febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
33
num At Risk
50
group Id
EG001
num Affected
24
num At Risk
51
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
9
num At Risk
50
group Id
EG001
num Affected
9
num At Risk
51
term
hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
22
num At Risk
50
group Id
EG001
num Affected
13
num At Risk
51
term
hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
12
num At Risk
50
group Id
EG001
num Affected
14
num At Risk
51
term
hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
26
num At Risk
50
group Id
EG001
num Affected
33
num At Risk
51
term
hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
51
term
hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
48
num At Risk
50
group Id
EG001
num Affected
44
num At Risk
51
term
nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
2
group Id
EG001
num Affected
1
num At Risk
51
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
2
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
50
num Events
4
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Escherichia Coli (E-Coli)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Pulmonary hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Idiopathic pneumonia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
group Id
EG001
num Affected
0
num At Risk
51
num Events
0
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
51
num Events
2
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
50
num Events
0
group Id
EG001
num Affected
1
num At Risk
51
num Events
1
term
Myocardial infarction

time Frame

Adverse event data were collected through one year post transplant

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Preserved source evidence · Not medical advice