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NCT02365597 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer · Source last updated 2026-08-28

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
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
Other-event reporting threshold
5%

The population included participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg

Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

14 / 3332 / 3331 / 33
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg

Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

39 / 7878 / 7862 / 78
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg

Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

47 / 101101 / 10183 / 101
Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg

Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

9 / 2525 / 253 / 25

Group identifiers: EG000: Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg · EG001: Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg · EG002: Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg · EG003: Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 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 Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Acute Coronary Syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Acute Myocardial Infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Myocardial Infarction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Angle Closure Glaucoma
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Corneal Erosion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Detachment of Retinal Pigment Epithelium
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Dry Eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Keratitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Maculopathy
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Optic Atrophy

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 Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      25
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Blepharitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
    term
    Chorioretinopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Dry Eye
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Keratitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      25
    term
    Lacrimation Increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Ocular Toxicity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
    term
    Punctate Keratitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
    term
    Retinal Detachment
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      25
    term
    Vision Blurred
Complete source fields
description
The population included participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    33
    description
    Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    33
    serious Num Affected
    14
    serious Num At Risk
    33
    title
    Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
  2. deaths Num Affected
    62
    deaths Num At Risk
    78
    description
    Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    EG001
    other Num Affected
    78
    other Num At Risk
    78
    serious Num Affected
    39
    serious Num At Risk
    78
    title
    Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
  3. deaths Num Affected
    83
    deaths Num At Risk
    101
    description
    Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    EG002
    other Num Affected
    101
    other Num At Risk
    101
    serious Num Affected
    47
    serious Num At Risk
    101
    title
    Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
  4. deaths Num Affected
    3
    deaths Num At Risk
    25
    description
    Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    EG003
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    9
    serious Num At Risk
    25
    title
    Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      25
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Blepharitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
    term
    Chorioretinopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Dry Eye
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Keratitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      25
    term
    Lacrimation Increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
    term
    Ocular Toxicity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
    term
    Punctate Keratitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
    term
    Retinal Detachment
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      25
    term
    Vision Blurred
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Acute Coronary Syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Acute Myocardial Infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Myocardial Infarction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Angle Closure Glaucoma
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Corneal Erosion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Detachment of Retinal Pigment Epithelium
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Dry Eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Keratitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Maculopathy
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
    term
    Optic Atrophy
time Frame
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months

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Preserved source evidence · Not medical advice