Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02548845 · ADVERSE EVENTS

Adverse events

An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain · Source last updated 2018-08-06

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
From the onset of the hyponatraemia episode until 6 weeks afterwards
Other-event reporting threshold
2%

Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oncology Patients With Hyponatraemia

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level \<135 mmol/L)

10 / 707 / 705 / 70

Group identifiers: EG000: Oncology Patients With Hyponatraemia

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Pleural effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Ascites
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Listless
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Oesophageal stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Delirium
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    General physical health deterioriation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Haemoptysis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Pain

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
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      3
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Anaemia
Complete source fields
description
Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    70
    description
    Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level \<135 mmol/L)
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    70
    serious Num Affected
    10
    serious Num At Risk
    70
    title
    Oncology Patients With Hyponatraemia
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      3
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Pleural effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Ascites
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Listless
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Oesophageal stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      70
      num Events
      3
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Delirium
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    General physical health deterioriation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Haemoptysis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Pain
time Frame
From the onset of the hyponatraemia episode until 6 weeks afterwards

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

Preserved source evidence · Not medical advice