NCT01449539 · ADVERSE EVENTS

Adverse events

Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization · Source last updated 2015-02-23

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: Approximately 6 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Hyperbaric Oxygen Therapy Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens	0 / 8	8 / 8	Not reported / Not reported

Group identifiers: EG000: Hyperbaric Oxygen Therapy

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
8
term
ALP Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Auditory/Ear-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
8
term
Bicarbonate decrease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
8
term
Creatinine Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Hypercalcemia

Complete source fields

event Groups

description
Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
0
serious Num At Risk
8
title
Hyperbaric Oxygen Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
8
term
ALP Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
8
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Auditory/Ear-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
8
term
Bicarbonate decrease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
8
term
Creatinine Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
term
Hypercalcemia

time Frame

Approximately 6 months.

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

Preserved source evidence · Not medical advice