Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00510068 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors · Source last updated 2015-07-01

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 10mg/Day

Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

84 / 204201 / 204Not reported / Not reported
Placebo

Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

52 / 203190 / 203Not reported / Not reported
Open Label - Everolimus 10mg

Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.

108 / 225218 / 225Not reported / Not reported

Group identifiers: EG000: Everolimus 10mg/Day · EG001: Placebo · EG002: Open Label - Everolimus 10mg

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
    16.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      225
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Cardiac failure congestive

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
    16.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      225
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      225
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      225
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      225
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      225
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      225
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      225
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      225
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      225
    term
    Aphthous stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      225
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      225
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      225
    term
    Diarrhoea
Complete source fields
event Groups
  1. description
    Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
    id
    EG000
    other Num Affected
    201
    other Num At Risk
    204
    serious Num Affected
    84
    serious Num At Risk
    204
    title
    Everolimus 10mg/Day
  2. description
    Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
    id
    EG001
    other Num Affected
    190
    other Num At Risk
    203
    serious Num Affected
    52
    serious Num At Risk
    203
    title
    Placebo
  3. description
    Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
    id
    EG002
    other Num Affected
    218
    other Num At Risk
    225
    serious Num Affected
    108
    serious Num At Risk
    225
    title
    Open Label - Everolimus 10mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      225
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      225
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      225
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      225
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      225
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      225
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      225
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      225
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      225
    term
    Aphthous stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      225
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      225
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      225
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      225
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      225
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      204
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      203
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      225
    term
    Cardiac failure congestive

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

Preserved source evidence · Not medical advice