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NCT02609828 · ADVERSE EVENTS

Adverse events

Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy · Source last updated 2023-02-16

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
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Other-event reporting threshold
2%

Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set was evaluated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.

52 / 7343 / 7323 / 73
Tanezumab 10 mg

Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.

9 / 98 / 91 / 9
Tanezumab 10/20 mg

Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.

1 / 11 / 11 / 1
Tanezumab 20 mg

Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.

62 / 7249 / 7221 / 72

Group identifiers: EG000: Placebo · EG001: Tanezumab 10 mg · EG002: Tanezumab 10/20 mg · EG003: Tanezumab 20 mg

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Iron deficiency anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      72
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Arrhythmia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Cardio-respiratory arrest
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Hypoacusis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Tinnitus

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      72
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Visual acuity reduced
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Abdominal hernia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      72
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      72
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Dyspepsia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      72
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Toothache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      72
    term
    Vomiting
Complete source fields
description
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set was evaluated.
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    73
    description
    Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    73
    serious Num Affected
    52
    serious Num At Risk
    73
    title
    Placebo
  2. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    9
    serious Num At Risk
    9
    title
    Tanezumab 10 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Tanezumab 10/20 mg
  4. deaths Num Affected
    21
    deaths Num At Risk
    72
    description
    Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
    id
    EG003
    other Num Affected
    49
    other Num At Risk
    72
    serious Num Affected
    62
    serious Num At Risk
    72
    title
    Tanezumab 20 mg
frequency Threshold
2
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      72
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Visual acuity reduced
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Abdominal hernia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      72
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      72
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Dyspepsia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      72
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Toothache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      72
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Iron deficiency anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      72
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Arrhythmia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Cardio-respiratory arrest
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      72
    term
    Tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Hypoacusis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      72
    term
    Tinnitus
time Frame
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)

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Preserved source evidence · Not medical advice