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NCT00789828 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

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
Serious Adverse Events were monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), 48 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) until LPLV, up to 4 years.
Other-event reporting threshold
5%

For safety, the reporting arms have been created on the basis of actual exposure to study treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Everolimus Treated (Core and Extension Period)

Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.

33 / 7877 / 78Not reported / Not reported
Placebo (Core) Then Everolimus Treated (Extension Period)

Participants who received placebo in core period and then received evrolimus treatment in extension period.

17 / 3333 / 33Not reported / Not reported
Placebo Treated (Core Period)

Participants who received placebo in core period.

3 / 66 / 6Not reported / Not reported

Group identifiers: EG000: Everolimus Treated (Core and Extension Period) · EG001: Placebo (Core) Then Everolimus Treated (Extension Period) · EG002: Placebo Treated (Core Period)

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 V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Gastrooesophageal reflux disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Large intestinal ulcer
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Mouth ulceration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Small intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Umbilical hernia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hypersensitivity

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 V17.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Ear pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Vertigo
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Enteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Mouth ulceration
Complete source fields
description
For safety, the reporting arms have been created on the basis of actual exposure to study treatment
event Groups
  1. description
    Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
    id
    EG000
    other Num Affected
    77
    other Num At Risk
    78
    serious Num Affected
    33
    serious Num At Risk
    78
    title
    Everolimus Treated (Core and Extension Period)
  2. description
    Participants who received placebo in core period and then received evrolimus treatment in extension period.
    id
    EG001
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    17
    serious Num At Risk
    33
    title
    Placebo (Core) Then Everolimus Treated (Extension Period)
  3. description
    Participants who received placebo in core period.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Placebo Treated (Core Period)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Ear pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Vertigo
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Enteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Mouth ulceration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Gastrooesophageal reflux disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Large intestinal ulcer
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Mouth ulceration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Small intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Umbilical hernia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA V17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hypersensitivity
time Frame
Serious Adverse Events were monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), 48 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) until LPLV, up to 4 years.

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Preserved source evidence · Not medical advice