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NCT01673646 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16

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 and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 1513 days.
Other-event reporting threshold
1%

Protocol allowed dose modification after month 3 and so analyzing AE separately was did not provide a clinically meaningful data.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pasireotide LAR 20mg

Enrolled patients were randomized to 20mg pasireotide LAR.

3 / 1111 / 110 / 11
Pasireotide LAR 40mg

Enrolled patients were randomized to 40mg pasireotide LAR.

3 / 1111 / 110 / 11
Pasireotide LAR 60mg

Enrolled patients were randomized to 60mg pasireotide LAR.

5 / 1111 / 110 / 11
Pasireotide LAR - All Participants (All Patieents)

Patients who were randomized to the study - regardless of whether they were in the Core or Extension phase.

11 / 3333 / 330 / 33

Group identifiers: EG000: Pasireotide LAR 20mg · EG001: Pasireotide LAR 40mg · EG002: Pasireotide LAR 60mg · EG003: Pasireotide LAR - All Participants (All Patieents)

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Sudden hearing loss
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Inguinal hernia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Large intestine polyp
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Bile duct stone
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Meningitis bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Diabetes mellitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Osteoarthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Persistent depressive disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Pulmonary embolism

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 (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Ventricular extrasystoles
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Eustachian tube patulous
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Thyroiditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Arteriosclerotic retinopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Blepharitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Conjunctival hyperaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Diabetic retinopathy
Complete source fields
description
Protocol allowed dose modification after month 3 and so analyzing AE separately was did not provide a clinically meaningful data.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Enrolled patients were randomized to 20mg pasireotide LAR.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    3
    serious Num At Risk
    11
    title
    Pasireotide LAR 20mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Enrolled patients were randomized to 40mg pasireotide LAR.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    3
    serious Num At Risk
    11
    title
    Pasireotide LAR 40mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Enrolled patients were randomized to 60mg pasireotide LAR.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Pasireotide LAR 60mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    33
    description
    Patients who were randomized to the study - regardless of whether they were in the Core or Extension phase.
    id
    EG003
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    11
    serious Num At Risk
    33
    title
    Pasireotide LAR - All Participants (All Patieents)
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Ventricular extrasystoles
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Eustachian tube patulous
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Thyroiditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Arteriosclerotic retinopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Blepharitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Conjunctival hyperaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Diabetic retinopathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Sudden hearing loss
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Inguinal hernia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Large intestine polyp
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Bile duct stone
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Meningitis bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Diabetes mellitus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Osteoarthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Persistent depressive disorder
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
    term
    Pulmonary embolism
time Frame
Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 1513 days.

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Preserved source evidence · Not medical advice