NCT01313897 · ADVERSE EVENTS

Adverse events

UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma · Source last updated 2017-05-19

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: Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Study Treatment Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)	6 / 8	8 / 8	3 / 8

Group identifiers: EG000: Study Treatment

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 4 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 4 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 4 Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Constitutional Symptoms - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Rigors/Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Skin Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Mucositis/Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 5 Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Infection - other

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
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 1 Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 1 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Grade 2 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 3 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 1 Blood - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Blood - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
8
term
Grade 1 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
8
term
Grade 2 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 3 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Grade 2 Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 3 Leukopenia

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
8
description
Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Study Treatment

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 1 Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 1 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Grade 2 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 3 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 1 Blood - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Blood - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
8
term
Grade 1 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
8
term
Grade 2 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 3 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Grade 2 Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
8
term
Grade 3 Leukopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 4 Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 4 Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
8
term
Grade 4 Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Constitutional Symptoms - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Rigors/Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Skin Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Mucositis/Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 2 Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 5 Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Grade 3 Infection - other

time Frame

Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.

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Preserved source evidence · Not medical advice