Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03441360 · ADVERSE EVENTS

Adverse events

Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS) · Source last updated 2022-10-05

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
From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Eribulin Mesylate 1.4 mg/m^2: RMS

Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

6 / 88 / 88 / 8
Eribulin Mesylate 1.4 mg/m^2: NRSTS

Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

2 / 88 / 87 / 8
Eribulin Mesylate 1.4 mg/m^2: EWS

Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

3 / 55 / 55 / 5

Group identifiers: EG000: Eribulin Mesylate 1.4 mg/m^2: RMS · EG001: Eribulin Mesylate 1.4 mg/m^2: NRSTS · EG002: Eribulin Mesylate 1.4 mg/m^2: EWS

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Neuralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Left ventricular dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Mouth haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Bone pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Costochondritis

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      24
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Mitral valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pulmonary valve disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tricuspid valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ear pain
Complete source fields
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    6
    serious Num At Risk
    8
    title
    Eribulin Mesylate 1.4 mg/m^2: RMS
  2. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    2
    serious Num At Risk
    8
    title
    Eribulin Mesylate 1.4 mg/m^2: NRSTS
  3. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Eribulin Mesylate 1.4 mg/m^2: EWS
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      24
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
      num Events
      16
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Mitral valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pulmonary valve disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tricuspid valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ear pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Neuralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Left ventricular dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    term
    Mouth haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Bone pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    term
    Costochondritis
time Frame
From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice