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NCT01794793 · ADVERSE EVENTS

Adverse events

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies · Source last updated 2024-10-01

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
Pasireotide s.c.: From start of study treatment up to 1 month after study treatment discontinuation (about 10 years) Pasireotide LAR: From start of study treatment up to 3 months after study treatment discontinuation (about 10 years)
Other-event reporting threshold
5%

Safety was monitored by collecting AEs/SAEs at every visit and throughout the study period (not limited to patient contact times) according to the sponsor's routine safety monitoring practices. Patients might have safety assessments performed by the clinic's local laboratory as per investigators judgement and standard of care at any time during the study period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Subjects

Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis

91 / 337220 / 3378 / 337

Group identifiers: EG000: All Subjects

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
    Hepatobiliary disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      337
    term
    Cholelithiasis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      337
    term
    Cholecystitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      337
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      337
    term
    Cellulitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiorespiratory arrest

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
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      337
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      337
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      337
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      337
    term
    Hyperglycaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      337
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      337
    term
    Covid-19
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      337
    term
    Urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      337
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      337
    term
    Diabetes mellitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      337
    term
    Diarrhoea
Complete source fields
description
Safety was monitored by collecting AEs/SAEs at every visit and throughout the study period (not limited to patient contact times) according to the sponsor's routine safety monitoring practices. Patients might have safety assessments performed by the clinic's local laboratory as per investigators judgement and standard of care at any time during the study period.
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    337
    description
    Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis
    id
    EG000
    other Num Affected
    220
    other Num At Risk
    337
    serious Num Affected
    91
    serious Num At Risk
    337
    title
    All Subjects
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      337
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      337
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      337
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      337
    term
    Hyperglycaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      337
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      337
    term
    Covid-19
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      337
    term
    Urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      337
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      337
    term
    Diabetes mellitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      337
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      337
    term
    Cholelithiasis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      337
    term
    Cholecystitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      337
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      337
    term
    Cellulitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      337
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEdDRa (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    term
    Cardiorespiratory arrest
time Frame
Pasireotide s.c.: From start of study treatment up to 1 month after study treatment discontinuation (about 10 years) Pasireotide LAR: From start of study treatment up to 3 months after study treatment discontinuation (about 10 years)

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