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NCT01713946 · ADVERSE EVENTS

Adverse events

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures · Source last updated 2018-11-07

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
Adverse Events were collected during everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years
Other-event reporting threshold
5%

The summary tables below include all adverse events starting or worsening on or after the first dose of everolimus, and starting no later than 30 days after the date of last dose of everolimus. Adverse events starting during the placebo period were not counted.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Everolimus LT Target of 3 to 7 ng/mL

Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL

50 / 117110 / 1171 / 117
Everolimus HT Target of 9 to 15 ng/mL

Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL

49 / 130126 / 1302 / 130
Everolimus Start Ext

Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.

38 / 114109 / 1141 / 114
Everolimus All

Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.

137 / 361345 / 3614 / 361

Group identifiers: EG000: Everolimus LT Target of 3 to 7 ng/mL · EG001: Everolimus HT Target of 9 to 15 ng/mL · EG002: Everolimus Start Ext · EG003: Everolimus All

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      361
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      361
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Blepharitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Meibomianitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Retinal detachment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Retinopathy proliferative

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      361
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      361
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      361
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      361
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      361
    term
    Aphthous ulcer
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      361
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      361
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      117
      num At Risk
      361
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      361
    term
    Mouth ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      361
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      130
      num At Risk
      361
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      79
      num At Risk
      361
    term
    Vomiting
Complete source fields
description
The summary tables below include all adverse events starting or worsening on or after the first dose of everolimus, and starting no later than 30 days after the date of last dose of everolimus. Adverse events starting during the placebo period were not counted.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    117
    description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
    id
    EG000
    other Num Affected
    110
    other Num At Risk
    117
    serious Num Affected
    50
    serious Num At Risk
    117
    title
    Everolimus LT Target of 3 to 7 ng/mL
  2. deaths Num Affected
    2
    deaths Num At Risk
    130
    description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
    id
    EG001
    other Num Affected
    126
    other Num At Risk
    130
    serious Num Affected
    49
    serious Num At Risk
    130
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. deaths Num Affected
    1
    deaths Num At Risk
    114
    description
    Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.
    id
    EG002
    other Num Affected
    109
    other Num At Risk
    114
    serious Num Affected
    38
    serious Num At Risk
    114
    title
    Everolimus Start Ext
  4. deaths Num Affected
    4
    deaths Num At Risk
    361
    description
    Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.
    id
    EG003
    other Num Affected
    345
    other Num At Risk
    361
    serious Num Affected
    137
    serious Num At Risk
    361
    title
    Everolimus All
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      361
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      361
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      361
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      361
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      361
    term
    Aphthous ulcer
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      361
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      361
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      117
      num At Risk
      361
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      102
      num At Risk
      361
    term
    Mouth ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      361
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      130
      num At Risk
      361
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      79
      num At Risk
      361
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      361
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      361
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Blepharitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Meibomianitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Retinal detachment
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      130
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      114
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      361
    term
    Retinopathy proliferative
time Frame
Adverse Events were collected during everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years

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Preserved source evidence · Not medical advice