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NCT00790400 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) · Source last updated 2017-02-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Everolimus Randomized (Core & Ext)

Patients who were randomized and treated with Everolimus during the Core and Extension phase

28 / 7979 / 79Not reported / Not reported
Placebo Randomized/Crossed Over to Everolimus

Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase

17 / 3333 / 33Not reported / Not reported
Placebo Randomized/Never Crossed-over

Patients randomized to placebo who never crossed-over to Everolimus

3 / 65 / 6Not reported / Not reported

Group identifiers: EG000: Everolimus Randomized (Core & Ext) · EG001: Placebo Randomized/Crossed Over to Everolimus · EG002: Placebo Randomized/Never Crossed-over

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 V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Bone marrow oedema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Cardiovascular insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vertigo positional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Visual acuity reduced
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal adhesions
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal compartment syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea haemorrhagic

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 V18.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      6
      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 V18.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hamartoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Aphthous stomatitis
Complete source fields
event Groups
  1. description
    Patients who were randomized and treated with Everolimus during the Core and Extension phase
    id
    EG000
    other Num Affected
    79
    other Num At Risk
    79
    serious Num Affected
    28
    serious Num At Risk
    79
    title
    Everolimus Randomized (Core & Ext)
  2. description
    Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
    id
    EG001
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    17
    serious Num At Risk
    33
    title
    Placebo Randomized/Crossed Over to Everolimus
  3. description
    Patients randomized to placebo who never crossed-over to Everolimus
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Placebo Randomized/Never Crossed-over
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      6
      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 V18.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Hamartoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    term
    Aphthous stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Bone marrow oedema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Cardiac failure congestive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Cardiovascular insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Vertigo positional
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Visual acuity reduced
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal adhesions
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal compartment syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Abdominal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    term
    Diarrhoea haemorrhagic

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice