NCT02703779 · ADVERSE EVENTS

Adverse events

Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM) · Source last updated 2021-06-18

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: From the time of signing the consent until 30 days after collection or up to 2 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stem Cell Collection Without In-vivo Purging With Bortezomib Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.	12 / 51	39 / 51	3 / 51
Stem Cell Collection With In-vivo Purging With Bortezomib Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.	24 / 50	39 / 50	1 / 50

Group identifiers: EG000: Stem Cell Collection Without In-vivo Purging With Bortezomib · EG001: Stem Cell Collection With In-vivo Purging With Bortezomib

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
8
num At Risk
51
num Events
8
group Id
EG001
num Affected
7
num At Risk
50
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
2
num At Risk
50
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
0
num At Risk
50
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
0
num At Risk
50
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
2
num At Risk
50
num Events
2
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
4
num At Risk
50
num Events
4
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Peripheral sensory neuropathy

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
26
group Id
EG001
num Affected
7
num At Risk
50
num Events
8
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
26
num At Risk
51
num Events
34
group Id
EG001
num Affected
27
num At Risk
50
num Events
33
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
11
num At Risk
51
num Events
11
group Id
EG001
num Affected
9
num At Risk
50
num Events
10
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
11
group Id
EG001
num Affected
8
num At Risk
50
num Events
10
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
10
num At Risk
51
num Events
10
group Id
EG001
num Affected
6
num At Risk
50
num Events
7
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
51
num Events
16
group Id
EG001
num Affected
14
num At Risk
50
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
29
num At Risk
51
num Events
55
group Id
EG001
num Affected
29
num At Risk
50
num Events
45
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
12
num At Risk
51
num Events
12
group Id
EG001
num Affected
6
num At Risk
50
num Events
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
12
num At Risk
51
num Events
14
group Id
EG001
num Affected
10
num At Risk
50
num Events
11
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
21
num At Risk
51
num Events
32
group Id
EG001
num Affected
21
num At Risk
50
num Events
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
11
num At Risk
51
num Events
12
group Id
EG001
num Affected
15
num At Risk
50
num Events
16
term
Generalized muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
14
group Id
EG001
num Affected
4
num At Risk
50
num Events
4
term
Hypertension

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
51
description
Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
id
EG000
other Num Affected
39
other Num At Risk
51
serious Num Affected
12
serious Num At Risk
51
title
Stem Cell Collection Without In-vivo Purging With Bortezomib
deaths Num Affected
1
deaths Num At Risk
50
description
Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
id
EG001
other Num Affected
39
other Num At Risk
50
serious Num Affected
24
serious Num At Risk
50
title
Stem Cell Collection With In-vivo Purging With Bortezomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
26
group Id
EG001
num Affected
7
num At Risk
50
num Events
8
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
26
num At Risk
51
num Events
34
group Id
EG001
num Affected
27
num At Risk
50
num Events
33
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
11
num At Risk
51
num Events
11
group Id
EG001
num Affected
9
num At Risk
50
num Events
10
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
11
group Id
EG001
num Affected
8
num At Risk
50
num Events
10
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
10
num At Risk
51
num Events
10
group Id
EG001
num Affected
6
num At Risk
50
num Events
7
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
51
num Events
16
group Id
EG001
num Affected
14
num At Risk
50
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
29
num At Risk
51
num Events
55
group Id
EG001
num Affected
29
num At Risk
50
num Events
45
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
12
num At Risk
51
num Events
12
group Id
EG001
num Affected
6
num At Risk
50
num Events
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
12
num At Risk
51
num Events
14
group Id
EG001
num Affected
10
num At Risk
50
num Events
11
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
21
num At Risk
51
num Events
32
group Id
EG001
num Affected
21
num At Risk
50
num Events
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
11
num At Risk
51
num Events
12
group Id
EG001
num Affected
15
num At Risk
50
num Events
16
term
Generalized muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
9
num At Risk
51
num Events
14
group Id
EG001
num Affected
4
num At Risk
50
num Events
4
term
Hypertension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
51
num Events
8
group Id
EG001
num Affected
7
num At Risk
50
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
2
num At Risk
50
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
0
num At Risk
50
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
51
num Events
1
group Id
EG001
num Affected
0
num At Risk
50
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
2
num At Risk
50
num Events
2
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
4
num At Risk
50
num Events
4
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
51
num Events
0
group Id
EG001
num Affected
1
num At Risk
50
num Events
1
term
Peripheral sensory neuropathy

time Frame

From the time of signing the consent until 30 days after collection or up to 2 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice