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NCT02564198 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors · Source last updated 2021-08-17

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
Baseline, up to 4 years 8 months
Other-event reporting threshold
5%

All randomized participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
8 mg/kg Ramucirumab (Part A)

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.

3 / 88 / 80 / 8
12 mg/kg Ramucirumab (Part A)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

7 / 1515 / 150 / 15
12 mg/kg Ramucirumab (Part B)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

2 / 66 / 60 / 6

Group identifiers: EG000: 8 mg/kg Ramucirumab (Part A) · EG001: 12 mg/kg Ramucirumab (Part A) · EG002: 12 mg/kg Ramucirumab (Part B)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Kidney infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bone pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tumour pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Peripheral motor neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Seizure

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      15
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ear pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eye pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Photophobia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain upper
Complete source fields
description
All randomized participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    8 mg/kg Ramucirumab (Part A)
  2. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    7
    serious Num At Risk
    15
    title
    12 mg/kg Ramucirumab (Part A)
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    12 mg/kg Ramucirumab (Part B)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      15
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ear pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eye pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Photophobia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Kidney infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bone pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tumour pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Peripheral motor neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Seizure
time Frame
Baseline, up to 4 years 8 months

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Preserved source evidence · Not medical advice