Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01582061 · ADVERSE EVENTS

Adverse events

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. · Source last updated 2018-06-19

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

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

Collection time frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 256 weeks
Other-event reporting threshold
5%

Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
600 µg Bid

600 µg bid

13 / 4949 / 490 / 49
900 µg Bid

900 µg bid

17 / 5554 / 551 / 55
All Patients

All patients

30 / 104103 / 1041 / 104

Group identifiers: EG000: 600 µg Bid · EG001: 900 µg Bid · EG002: All Patients

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 (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Glucocorticoid deficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Hyperprolactinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pituitary-dependent Cushing's syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      104
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Gastrointestinal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pancreatitis necrotising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Death

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
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      104
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      104
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      104
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      104
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      104
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      104
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      104
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Faeces soft
Complete source fields
description
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    49
    description
    600 µg bid
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    13
    serious Num At Risk
    49
    title
    600 µg Bid
  2. deaths Num Affected
    1
    deaths Num At Risk
    55
    description
    900 µg bid
    id
    EG001
    other Num Affected
    54
    other Num At Risk
    55
    serious Num Affected
    17
    serious Num At Risk
    55
    title
    900 µg Bid
  3. deaths Num Affected
    1
    deaths Num At Risk
    104
    description
    All patients
    id
    EG002
    other Num Affected
    103
    other Num At Risk
    104
    serious Num Affected
    30
    serious Num At Risk
    104
    title
    All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      104
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      104
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      104
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      104
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      104
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      104
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      104
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      104
    term
    Faeces soft
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Glucocorticoid deficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Hyperprolactinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pituitary-dependent Cushing's syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      104
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Gastrointestinal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Pancreatitis necrotising
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      104
    term
    Death
time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 256 weeks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice