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NCT00412061 · ADVERSE EVENTS

Adverse events

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor · Source last updated 2014-11-21

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%

Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Everolimus + Octreotide

Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

126 / 215214 / 215Not reported / Not reported
Placebo + Octreotide

Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

74 / 211194 / 211Not reported / Not reported
Everolimus Open Label

Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.

93 / 170162 / 170Not reported / Not reported

Group identifiers: EG000: Everolimus + Octreotide · EG001: Placebo + Octreotide · EG002: Everolimus Open Label

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
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      170
    term
    Haemorrhagic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Aortic valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Atrial fibrillation

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
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      170
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      170
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      170
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      170
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      170
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      170
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      170
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      170
    term
    Aphthous stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      170
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      77
      num At Risk
      170
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      170
    term
    Dry mouth
Complete source fields
description
Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment
event Groups
  1. description
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    id
    EG000
    other Num Affected
    214
    other Num At Risk
    215
    serious Num Affected
    126
    serious Num At Risk
    215
    title
    Everolimus + Octreotide
  2. description
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    id
    EG001
    other Num Affected
    194
    other Num At Risk
    211
    serious Num Affected
    74
    serious Num At Risk
    211
    title
    Placebo + Octreotide
  3. description
    Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
    id
    EG002
    other Num Affected
    162
    other Num At Risk
    170
    serious Num Affected
    93
    serious Num At Risk
    170
    title
    Everolimus Open Label
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      170
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      170
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      170
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      170
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      170
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      170
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      170
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      170
    term
    Aphthous stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      170
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      170
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      77
      num At Risk
      170
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      170
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      170
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      170
    term
    Haemorrhagic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Aortic valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      170
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      215
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      170
    term
    Atrial fibrillation

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

Preserved source evidence · Not medical advice