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NCT02411448 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) · Source last updated 2026-01-16

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
Up To 3 Years
Other-event reporting threshold
5%

Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: Ramucirumab + Erlotinib

Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

0 / 1414 / 142 / 14
Part B: Ramucirumab + Erlotinib

Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

65 / 221220 / 22137 / 224
Part B: Placebo + Erlotinib

Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

47 / 225225 / 22542 / 225

Group identifiers: EG000: Part A: Ramucirumab + Erlotinib · EG001: Part B: Ramucirumab + Erlotinib · EG002: Part B: Placebo + Erlotinib

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Wolff-parkinson-white syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      3
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Macular fibrosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      4
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Colitis

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      221
      num Events
      49
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      225
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      11
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      221
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      221
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      225
      num Events
      5
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      221
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      225
      num Events
      11
    term
    Blepharitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      221
      num Events
      27
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      225
      num Events
      24
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Eyelid oedema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Ocular discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      2
    term
    Ocular hyperaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      2
    term
    Abdominal discomfort
Complete source fields
description
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    14
    description
    Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    0
    serious Num At Risk
    14
    title
    Part A: Ramucirumab + Erlotinib
  2. deaths Num Affected
    37
    deaths Num At Risk
    224
    description
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    EG001
    other Num Affected
    220
    other Num At Risk
    221
    serious Num Affected
    65
    serious Num At Risk
    221
    title
    Part B: Ramucirumab + Erlotinib
  3. deaths Num Affected
    42
    deaths Num At Risk
    225
    description
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    EG002
    other Num Affected
    225
    other Num At Risk
    225
    serious Num Affected
    47
    serious Num At Risk
    225
    title
    Part B: Placebo + Erlotinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      221
      num Events
      49
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      225
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      11
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      221
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      221
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      225
      num Events
      5
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      221
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      225
      num Events
      11
    term
    Blepharitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      221
      num Events
      27
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      225
      num Events
      24
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Eyelid oedema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Ocular discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      221
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      2
    term
    Ocular hyperaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      2
    term
    Abdominal discomfort
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Wolff-parkinson-white syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      225
      num Events
      3
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      1
    term
    Macular fibrosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      221
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
      num Events
      4
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      221
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
      num Events
      0
    term
    Colitis
time Frame
Up To 3 Years

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Preserved source evidence · Not medical advice