Trial Outcomes & Findings for Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment (NCT NCT02099266)
NCT ID: NCT02099266
Last Updated: 2017-06-12
Results Overview
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Toxicity assessment with 24hrs of treatment
Results posted on
2017-06-12
Participant Flow
Participant milestones
| Measure |
Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Treatment
n=15 Participants
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Toxicity assessment with 24hrs of treatmentPopulation: One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment
n=15 Participants
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
Myeloablative Conditioning
Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:
Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV
|
|---|---|---|
|
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
grade IV leukopenia
|
15 Participants
|
—
|
|
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
grade III/IV neutropenia
|
12 Participants
|
—
|
|
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
grade III/IV anemia
|
12 Participants
|
—
|
|
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
grade III/IV thrombocytopenia
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Daily measurement of neutrophil counts up to 90 days post transplant.Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level \>/= 500 u/L.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment
n=9 Participants
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
Myeloablative Conditioning
n=6 Participants
Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:
Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV
|
|---|---|---|
|
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
|
7 Days
Interval 6.0 to 17.0
|
24.5 Days
Interval 16.0 to 45.0
|
SECONDARY outcome
Timeframe: 28 daysComplete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment
n=9 Participants
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
Myeloablative Conditioning
Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:
Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV
|
|---|---|---|
|
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
|
7 Participants
|
—
|
Adverse Events
Hyperbaric Oxygen Treatment
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyperbaric Oxygen Treatment
n=15 participants at risk
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Upper Respiratory infection
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
Other adverse events
| Measure |
Hyperbaric Oxygen Treatment
n=15 participants at risk
Administration of hyperbaric oxygen the morning of UCB transplant.
Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 5 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Acidosis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Immune system disorders
Allergic reaction
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Anal pain
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
12/15 • Number of events 87 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Psychiatric disorders
Anxiety
|
33.3%
5/15 • Number of events 6 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Bloating
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
26.7%
4/15 • Number of events 5 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Investigations
Blood bilirubin increased
|
26.7%
4/15 • Number of events 5 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Chills
|
40.0%
6/15 • Number of events 6 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Concentration impairment
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
6/15 • Number of events 7 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Cystitis noninfective
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Psychiatric disorders
Depression
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
9/15 • Number of events 13 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Edema face
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Edema limbs
|
40.0%
6/15 • Number of events 10 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Edema trunk
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Esophagitis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Eye disorders
Eye disorders - Other, specify
|
13.3%
2/15 • Number of events 6 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Facial pain
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Fatigue
|
53.3%
8/15 • Number of events 9 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
5/15 • Number of events 7 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Flu like symptoms
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Gait disturbance
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
40.0%
6/15 • Number of events 9 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Reproductive system and breast disorders
Genital edema
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Psychiatric disorders
Hallucinations
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
20.0%
3/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
46.7%
7/15 • Number of events 8 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
60.0%
9/15 • Number of events 11 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
40.0%
6/15 • Number of events 9 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Infusion related reaction
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Lip pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Localized edema
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Malaise
|
33.3%
5/15 • Number of events 5 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.7%
1/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
6/15 • Number of events 7 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Nausea
|
73.3%
11/15 • Number of events 16 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Investigations
Neutrophil count decreased
|
80.0%
12/15 • Number of events 70 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Oral pain
|
26.7%
4/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
General disorders
Pain
|
33.3%
5/15 • Number of events 5 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Papulopustular rash
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Paresthesia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Investigations
platelet count decreased
|
93.3%
14/15 • Number of events 114 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
5/15 • Number of events 7 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
6/15 • Number of events 12 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
13.3%
2/15 • Number of events 6 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Eye disorders
Scleral disorder
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Sepsis
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Sinus pain
|
6.7%
1/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Cardiac disorders
Sinus tachycardia
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
26.7%
4/15 • Number of events 6 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.3%
2/15 • Number of events 2 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Toothache
|
13.3%
2/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Renal and urinary disorders
Urinary urgency
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
20.0%
3/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 4 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Eye disorders
Watering eyes
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Investigations
Weight loss
|
20.0%
3/15 • Number of events 3 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Investigations
White blood cell decreased
|
100.0%
15/15 • Number of events 86 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
1/15 • Number of events 1 • Adverse clinical events experienced by participants will be collected and reported from initiation of HBO treatment and through engraftment or day +90, whichever comes first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place