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NCT03398200 · ADVERSE EVENTS

Adverse events

Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma · Source last updated 2025-02-07

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
100 days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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).

12 / 5249 / 520 / 52
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.

9 / 4739 / 470 / 47

Group identifiers: EG000: Hyperbaric Oxygen Therapy · EG001: No 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.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Enterocolitis Infectious
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Acute Kidney Injury
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Immune System Disorders - Other, Engraftment Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Infections & Infestations - Other, Bacteremia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Lung Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Fever

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      47
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      47
    term
    Acute Kidney Injury
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      47
    term
    ALT Increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      47
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      47
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      47
    term
    Anxiety
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      47
    term
    Arthralgia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      47
    term
    AST Increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      47
    term
    Back Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      47
    term
    Blood Bilirubin Increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      47
    term
    Blurred Vision
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    52
    description
    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).
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    52
    serious Num Affected
    12
    serious Num At Risk
    52
    title
    Hyperbaric Oxygen Therapy
  2. deaths Num Affected
    0
    deaths Num At Risk
    47
    description
    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.
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    47
    serious Num Affected
    9
    serious Num At Risk
    47
    title
    No Hyperbaric Oxygen Therapy
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      47
    term
    Abdominal Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      47
    term
    Acute Kidney Injury
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      47
    term
    ALT Increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      47
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      47
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      47
    term
    Anxiety
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      47
    term
    Arthralgia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      47
    term
    AST Increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      47
    term
    Back Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      47
    term
    Blood Bilirubin Increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      47
    term
    Blurred Vision
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Enterocolitis Infectious
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Acute Kidney Injury
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Febrile Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Immune System Disorders - Other, Engraftment Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Infections & Infestations - Other, Bacteremia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Lung Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      47
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      47
    term
    Fever
time Frame
100 days

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