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NCT02354508 · ADVERSE EVENTS

Adverse events

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10

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) were collected from first dose of study treatment until end of study treatment plus 84 days post treatment, up to maximum duration of 76 weeks.
Other-event reporting threshold
2%

AE is any sign or symptom that occurs during the study treatment plus the 84 days post treatment. This is a single-arm study that evaluated the efficacy of Pasireotide LAR 40mmg and 60 mg. The Lanreotide and Octreotide arms were not really arms. These arms represent the drugs that the participants were on before being enrolled in the Pasireotide LAR arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Up-titrated to Pasireotide LAR 60 mg

Patients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.

6 / 9283 / 920 / 92
Pasireotide LAR Overall

This is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase

12 / 123112 / 1230 / 123

Group identifiers: EG000: Up-titrated to Pasireotide LAR 60 mg · EG001: Pasireotide LAR Overall

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Stress cardiomyopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      123
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Bile duct stone
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Biliary dilatation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      123
    term
    Cholelithiasis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Tonsillitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Hyperglycaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Ketoacidosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Nose deformity

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      123
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      123
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      123
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      123
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      123
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
    term
    Injection site pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      123
    term
    Cholelithiasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Hepatic steatosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      123
    term
    Bronchitis
Complete source fields
description
AE is any sign or symptom that occurs during the study treatment plus the 84 days post treatment. This is a single-arm study that evaluated the efficacy of Pasireotide LAR 40mmg and 60 mg. The Lanreotide and Octreotide arms were not really arms. These arms represent the drugs that the participants were on before being enrolled in the Pasireotide LAR arm.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    92
    description
    Patients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.
    id
    EG000
    other Num Affected
    83
    other Num At Risk
    92
    serious Num Affected
    6
    serious Num At Risk
    92
    title
    Up-titrated to Pasireotide LAR 60 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    123
    description
    This is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    EG001
    other Num Affected
    112
    other Num At Risk
    123
    serious Num Affected
    12
    serious Num At Risk
    123
    title
    Pasireotide LAR Overall
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      123
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      123
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      123
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      123
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      123
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      123
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
    term
    Injection site pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      123
    term
    Cholelithiasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
    term
    Hepatic steatosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      123
    term
    Bronchitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Stress cardiomyopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      123
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Bile duct stone
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Biliary dilatation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      123
    term
    Cholelithiasis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Tonsillitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Hyperglycaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Ketoacidosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      92
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
    term
    Nose deformity
time Frame
Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 84 days post treatment, up to maximum duration of 76 weeks.

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