NCT03480360 · ADVERSE EVENTS

Adverse events

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression · Source last updated 2026-07-17

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: Monitoring of all acute toxicities (grade 3 or higher) occurred until the time of discharge (post-transplant). After discharge, until day 100, only serious toxicities (grade 4 or higher) were recorded. All-Cause Mortality was monitored from the time of transplant to three years post-transplant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Johns Hopkins' Conditioning Regimen Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight	3 / 20	16 / 20	5 / 20

Group identifiers: EG000: Johns Hopkins' Conditioning Regimen

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Probably related to pseudo-gout
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Edema Limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
GI GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Liver GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Skin GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
2
term
Encephalopathy

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
15
num At Risk
20
num Events
18
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Rigors
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
4
term
Dysrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
5
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
C. Diff
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Encephalopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
3
term
Delirium
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Dysesthesia

Complete source fields

event Groups

deaths Num Affected
5
deaths Num At Risk
20
description
Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
id
EG000
other Num Affected
16
other Num At Risk
20
serious Num Affected
3
serious Num At Risk
20
title
Johns Hopkins' Conditioning Regimen

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
15
num At Risk
20
num Events
18
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
4
num At Risk
20
num Events
4
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Rigors
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
3
num At Risk
20
num Events
4
term
Dysrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
5
num At Risk
20
num Events
5
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
C. Diff
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Encephalopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
3
term
Delirium
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
2
num At Risk
20
num Events
2
term
Dysesthesia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Probably related to pseudo-gout
organ System
General disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Edema Limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
GI GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Liver GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Skin GVHD
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
1
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTC 4.0
stats
group Id
EG000
num Affected
1
num At Risk
20
num Events
2
term
Encephalopathy

time Frame

Monitoring of all acute toxicities (grade 3 or higher) occurred until the time of discharge (post-transplant). After discharge, until day 100, only serious toxicities (grade 4 or higher) were recorded. All-Cause Mortality was monitored from the time of transplant to three years post-transplant.

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Preserved source evidence · Not medical advice