NCT03870451 · ADVERSE EVENTS

Adverse events

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma · Source last updated 2026-10-13

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 at initiation of treatment (day 0, week 1), at week 4, and week 8 visits. One enrolled participant was never treated and no adverse event data was collected on that participant, but that participant was followed for all cause mortality.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Grade 2-3 Established Neuropathy VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device	0 / 11	9 / 11	0 / 12
Grade 1-2 New-onset Neuropathy VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device	0 / 6	2 / 6	0 / 6

Group identifiers: EG000: Grade 2-3 Established Neuropathy · EG001: Grade 1-2 New-onset Neuropathy

Serious adverse events

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

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
General disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Muscle cramp
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
5
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Dysesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
7
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Paresthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
7
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Pruritus

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
12
description
VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
id
EG000
other Num Affected
9
other Num At Risk
11
serious Num Affected
0
serious Num At Risk
11
title
Grade 2-3 Established Neuropathy
deaths Num Affected
0
deaths Num At Risk
6
description
VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
id
EG001
other Num Affected
2
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
Grade 1-2 New-onset Neuropathy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Muscle cramp
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
5
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Dysesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
7
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Paresthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
7
group Id
EG001
num Affected
1
num At Risk
6
num Events
2
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE version 5
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Pruritus

time Frame

Adverse events were collected at initiation of treatment (day 0, week 1), at week 4, and week 8 visits. One enrolled participant was never treated and no adverse event data was collected on that participant, but that participant was followed for all cause mortality.

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Preserved source evidence · Not medical advice