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NCT02420223 · ADVERSE EVENTS

Adverse events

Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients · Source last updated 2021-06-07

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Propranolol

Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol

2 / 1212 / 120 / 12
Control Arm

Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.

3 / 1313 / 130 / 13

Group identifiers: EG000: Propranolol · EG001: Control Arm

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
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Edema of limb
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Eye infection

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atelectasis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Back pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Enterocolitis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Flushing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Hyperglycemia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    12
    description
    Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Propranolol
  2. deaths Num Affected
    0
    deaths Num At Risk
    13
    description
    Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Control Arm
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atelectasis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Back pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dyspnea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Enterocolitis infectious
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Flushing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Hyperglycemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Edema of limb
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Eye infection
time Frame
100 Days

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