Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01371643 · ADVERSE EVENTS

Adverse events

Surgical Debulking of Pituitary Adenomas · Source last updated 2016-08-29

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Medical Treatment by Octreotide LAR

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR

0 / 155 / 15Not reported / Not reported
Surgical Debulking Followed by Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery

1 / 2612 / 26Not reported / Not reported

Group identifiers: EG000: Medical Treatment by Octreotide LAR · EG001: Surgical Debulking Followed by Octreotide LAR

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Hyponatremia with Abdominal Discomfort

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      26
      num Events
      19
    term
    Nausea/Vomiting/Diarrhea/Bloating/Constipation/GI distress
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      26
      num Events
      7
    term
    Headaches
  3. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Pain at the Injection site
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Otitis Media
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Seizures (Seizure disorder since childhood)
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Dry nose
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Fatigue
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Back Pain
  9. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Urinary Tract Infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      5
    term
    Respiratory Infections/Cold symptoms/ Cough
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Sinus irritation/pressure
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Thyroiditis
Complete source fields
event Groups
  1. description
    Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery Octreotide LAR
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    15
    serious Num Affected
    0
    serious Num At Risk
    15
    title
    Medical Treatment by Octreotide LAR
  2. description
    Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured Octreotide LAR transsphenoidal surgery
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    26
    serious Num Affected
    1
    serious Num At Risk
    26
    title
    Surgical Debulking Followed by Octreotide LAR
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      26
      num Events
      19
    term
    Nausea/Vomiting/Diarrhea/Bloating/Constipation/GI distress
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      26
      num Events
      7
    term
    Headaches
  3. organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Pain at the Injection site
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Otitis Media
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Seizures (Seizure disorder since childhood)
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Dry nose
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Fatigue
  8. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Back Pain
  9. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Urinary Tract Infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      5
    term
    Respiratory Infections/Cold symptoms/ Cough
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Sinus irritation/pressure
  12. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Thyroiditis
serious Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Hyponatremia with Abdominal Discomfort

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

Preserved source evidence · Not medical advice