NCT02259348 · ADVERSE EVENTS

Adverse events

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation · Source last updated 2017-05-30

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 study enrollment through off-study date (up to 16 months).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Participants Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.	5 / 6	6 / 6	Not reported / Not reported

Group identifiers: EG000: Participants

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
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hemorrhage, pulmonary
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hepatic failure (disorder)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, candida glabrata, GI tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, culture negative, sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, enterococcus faecalis, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, escherichia coli, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, klebsiella oxytoca, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, pseudomonas aeruginosa, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, staphylococcus epidermidis, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, toxoplasmosis, cerebrospinal fluid
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Seizure

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
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
7
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Left ventricular systolic dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
4
term
Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Pneumatosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Epistaxis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hemorrhage, gastrointestinal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Abscess, mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
6
num Events
10
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Infection, adenovirus, respiratory tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
7
term
Infection, adenovirus, stool
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, BK virus, blood

Complete source fields

event Groups

description
Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Participants

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
7
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Left ventricular systolic dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
4
term
Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Pneumatosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Epistaxis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hemorrhage, gastrointestinal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Abscess, mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
6
num Events
10
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Infection, adenovirus, respiratory tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
num Events
7
term
Infection, adenovirus, stool
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, BK virus, blood

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hemorrhage, pulmonary
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hepatic failure (disorder)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, candida glabrata, GI tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, culture negative, sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, enterococcus faecalis, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, escherichia coli, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, klebsiella oxytoca, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, pseudomonas aeruginosa, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, staphylococcus epidermidis, blood
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Infection, toxoplasmosis, cerebrospinal fluid
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
term
Seizure

time Frame

Adverse events were collected from study enrollment through off-study date (up to 16 months).

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Preserved source evidence · Not medical advice