NCT00368355 · ADVERSE EVENTS

Adverse events

T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts · Source last updated 2020-01-21

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 events were collected from the time participants started preparative regimen to 100 days post transplant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
CLINIMACS Device Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0	14 / 18	13 / 18	2 / 18
ISOLEX Device Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0	15 / 28	23 / 28	4 / 28

Group identifiers: EG000: CLINIMACS Device · EG001: ISOLEX Device

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
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Ventricular Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Gastrointestinal-Other: Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
2
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
pharyngeal ulcers
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Hematuria (in the absence of vaginal bleeding)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Liver Dysfunction/Failure (clinical)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
SGOT (AST) (serum glutamic oxaloacetic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
SGPT (ALT) (serum glutamic pyruvic transaminase)

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
Immune system disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Fatigue (lethargy, malaise, asthenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Rash/Desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
3
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
Diarrhea patients without colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Vaginal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
7
num At Risk
28
num Events
10
term
GGT (Gamma-Glutamyl transpeptidase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
Hepatic enlargement
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Portal vein flow

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
18
description
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
id
EG000
other Num Affected
13
other Num At Risk
18
serious Num Affected
14
serious Num At Risk
18
title
CLINIMACS Device
deaths Num Affected
4
deaths Num At Risk
28
description
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
id
EG001
other Num Affected
23
other Num At Risk
28
serious Num Affected
15
serious Num At Risk
28
title
ISOLEX Device

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Fatigue (lethargy, malaise, asthenia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Rash/Desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
3
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
Diarrhea patients without colostomy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Vaginal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
7
num At Risk
28
num Events
10
term
GGT (Gamma-Glutamyl transpeptidase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
Hepatic enlargement
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Portal vein flow

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Ventricular Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Gastrointestinal-Other: Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
2
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
pharyngeal ulcers
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Hematuria (in the absence of vaginal bleeding)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Liver Dysfunction/Failure (clinical)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
SGOT (AST) (serum glutamic oxaloacetic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE V2
stats
group Id
EG000
num Affected
0
num At Risk
18
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
SGPT (ALT) (serum glutamic pyruvic transaminase)

time Frame

Adverse events were collected from the time participants started preparative regimen to 100 days post transplant.

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Preserved source evidence · Not medical advice