Trial Outcomes & Findings for Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma (NCT NCT03398200)
NCT ID: NCT03398200
Last Updated: 2025-02-07
Results Overview
Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count \>=0.5 thou/ul after nadir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
100 days
Results posted on
2025-02-07
Participant Flow
Participant milestones
| Measure |
Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
47
|
|
Overall Study
COMPLETED
|
52
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
63 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
47 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysTime from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count \>=0.5 thou/ul after nadir.
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=46 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Time From Transplant to Neutrophil Count Recovery
|
12 days
Interval 12.0 to 13.0
|
12 days
Interval 12.0 to 13.0
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Time From Transplant to Absolute Lymphocyte Recovery
|
12 Days
Interval 12.0 to 13.0
|
13 Days
Interval 12.0 to 14.0
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Number of Days of Granulocyte Colony-stimulating Factor
|
6 Days
Interval 5.0 to 7.0
|
6 Days
Interval 6.0 to 6.0
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Number of Units of Packed Red Blood Cells Received
|
0 units
Interval 0.0 to 1.0
|
0 units
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=44 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=42 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Length of Hospital Stay
|
13 Days
Interval 13.0 to 14.0
|
14 Days
Interval 13.0 to 14.0
|
SECONDARY outcome
Timeframe: 1 yearA progressive response is defined as follows: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be \> 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder Anyone who did not have a progressive response was considered as progression free survival.
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=52 Participants
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 Participants
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Percentage of Participants With Progressive Free Survival
|
91.3 percentage of participants
Interval 78.2 to 96.7
|
92.6 percentage of participants
Interval 78.6 to 97.6
|
Adverse Events
Hyperbaric Oxygen Therapy
Serious events: 12 serious events
Other events: 49 other events
Deaths: 0 deaths
No Hyperbaric Oxygen Therapy
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyperbaric Oxygen Therapy
n=52 participants at risk
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 participants at risk
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Infections and infestations
Enterocolitis Infectious
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Cardiac disorders
Atrial Fibrillation
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Infections and infestations
Sepsis
|
7.7%
4/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Immune system disorders
Constipation
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.9%
1/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Immune system disorders
Immune System Disorders - Other, Engraftment Syndrome
|
5.8%
3/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Infections and infestations
Infections & Infestations - Other, Bacteremia
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Infections and infestations
Lung Infection
|
1.9%
1/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Immune system disorders
Nausea
|
1.9%
1/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
General disorders
Fatigue
|
0.00%
0/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
General disorders
Fever
|
0.00%
0/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Infections and infestations
Infections & Infestations - Other, MRSA
|
0.00%
0/52 • 100 days
|
4.3%
2/47 • 100 days
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/52 • 100 days
|
2.1%
1/47 • 100 days
|
Other adverse events
| Measure |
Hyperbaric Oxygen Therapy
n=52 participants at risk
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
|
No Hyperbaric Oxygen Therapy
n=47 participants at risk
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
34.6%
18/52 • 100 days
|
17.0%
8/47 • 100 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.9%
1/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Investigations
ALT Increased
|
11.5%
6/52 • 100 days
|
19.1%
9/47 • 100 days
|
|
Blood and lymphatic system disorders
Anemia
|
59.6%
31/52 • 100 days
|
48.9%
23/47 • 100 days
|
|
Metabolism and nutrition disorders
Anorexia
|
26.9%
14/52 • 100 days
|
29.8%
14/47 • 100 days
|
|
Psychiatric disorders
Anxiety
|
7.7%
4/52 • 100 days
|
29.8%
14/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Investigations
AST Increased
|
9.6%
5/52 • 100 days
|
12.8%
6/47 • 100 days
|
|
Cardiac disorders
atrial fibrillation
|
5.8%
3/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.3%
9/52 • 100 days
|
17.0%
8/47 • 100 days
|
|
Investigations
Blood Bilirubin Increased
|
9.6%
5/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Eye disorders
Blurred Vision
|
1.9%
1/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
13.5%
7/52 • 100 days
|
14.9%
7/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.8%
3/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
General disorders
Chills
|
13.5%
7/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Gastrointestinal disorders
Colitis
|
5.8%
3/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Gastrointestinal disorders
Constipation
|
36.5%
19/52 • 100 days
|
34.0%
16/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
7/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Investigations
Creatinine Increased
|
5.8%
3/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Gastrointestinal disorders
Diarrhea
|
71.2%
37/52 • 100 days
|
76.6%
36/47 • 100 days
|
|
Nervous system disorders
Dizziness
|
17.3%
9/52 • 100 days
|
25.5%
12/47 • 100 days
|
|
Gastrointestinal disorders
Dry Mouth
|
3.8%
2/52 • 100 days
|
21.3%
10/47 • 100 days
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
8/52 • 100 days
|
14.9%
7/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
7/52 • 100 days
|
14.9%
7/47 • 100 days
|
|
Ear and labyrinth disorders
Ear & Labyrinth Disorders - Other, Ear Popping
|
9.6%
5/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorders - Other, Ear Pressure
|
5.8%
3/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Ear and labyrinth disorders
Ear Pain
|
11.5%
6/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Gastrointestinal disorders
Edema Limbs
|
23.1%
12/52 • 100 days
|
23.4%
11/47 • 100 days
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
3/52 • 100 days
|
4.3%
2/47 • 100 days
|
|
General disorders
Fatigue
|
69.2%
36/52 • 100 days
|
63.8%
30/47 • 100 days
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
57.7%
30/52 • 100 days
|
48.9%
23/47 • 100 days
|
|
General disorders
Fever
|
5.8%
3/52 • 100 days
|
14.9%
7/47 • 100 days
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, abdominal crampin
|
7.7%
4/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Nervous system disorders
Headache
|
25.0%
13/52 • 100 days
|
25.5%
12/47 • 100 days
|
|
Renal and urinary disorders
Hematuria
|
5.8%
3/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.6%
5/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
6/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Vascular disorders
Hypertension
|
26.9%
14/52 • 100 days
|
27.7%
13/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.3%
22/52 • 100 days
|
38.3%
18/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
76.9%
40/52 • 100 days
|
78.7%
37/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
38.5%
20/52 • 100 days
|
57.4%
27/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.1%
12/52 • 100 days
|
29.8%
14/47 • 100 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
1/52 • 100 days
|
12.8%
6/47 • 100 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
57.7%
30/52 • 100 days
|
70.2%
33/47 • 100 days
|
|
Vascular disorders
Hypotension
|
25.0%
13/52 • 100 days
|
21.3%
10/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.5%
7/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Immune system disorders
Immune System Disorders - Other, Engraftment Syndrome
|
7.7%
4/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Infections and infestations
Infections & Infestations - Other, Bacteremia
|
7.7%
4/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
Psychiatric disorders
Insomnia
|
32.7%
17/52 • 100 days
|
31.9%
15/47 • 100 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
76.9%
40/52 • 100 days
|
78.7%
37/47 • 100 days
|
|
Infections and infestations
Lung Infection
|
5.8%
3/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
69.2%
36/52 • 100 days
|
72.3%
34/47 • 100 days
|
|
Metabolism and nutrition disorders
Metabolism & nutritional disorders - other, insufficient oral intake
|
1.9%
1/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Gastrointestinal disorders
Mucositis Oral
|
42.3%
22/52 • 100 days
|
36.2%
17/47 • 100 days
|
|
General disorders
Myalgia
|
9.6%
5/52 • 100 days
|
8.5%
4/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.6%
5/52 • 100 days
|
4.3%
2/47 • 100 days
|
|
Gastrointestinal disorders
Nausea
|
80.8%
42/52 • 100 days
|
76.6%
36/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.8%
3/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
80.8%
42/52 • 100 days
|
80.9%
38/47 • 100 days
|
|
General disorders
Non-Cardiac Chest Pain
|
1.9%
1/52 • 100 days
|
10.6%
5/47 • 100 days
|
|
General disorders
Pain
|
1.9%
1/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.8%
2/52 • 100 days
|
14.9%
7/47 • 100 days
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
19.2%
10/52 • 100 days
|
23.4%
11/47 • 100 days
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
0.00%
0/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
9.6%
5/52 • 100 days
|
4.3%
2/47 • 100 days
|
|
Renal and urinary disorders
Renal & Urinary Disorders - Other, Dysuria
|
5.8%
3/52 • 100 days
|
4.3%
2/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic & Mediastinal Disorders - Other, runny nose
|
5.8%
3/52 • 100 days
|
0.00%
0/47 • 100 days
|
|
Cardiac disorders
Sinus Bradycardia
|
1.9%
1/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Cardiac disorders
Sinus Tachycardia
|
30.8%
16/52 • 100 days
|
23.4%
11/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
78.8%
41/52 • 100 days
|
83.0%
39/47 • 100 days
|
|
Vascular disorders
Thromboembolic Event
|
9.6%
5/52 • 100 days
|
2.1%
1/47 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
9.6%
5/52 • 100 days
|
6.4%
3/47 • 100 days
|
|
Gastrointestinal disorders
Vomiting
|
42.3%
22/52 • 100 days
|
40.4%
19/47 • 100 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place