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NCT00229203 · ADVERSE EVENTS

Adverse events

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma · Source last updated 2009-12-24

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
5%

32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone

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

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.

32 / 5151 / 51Not reported / Not reported
Plitidepsin + Dexamethasone

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

11 / 1919 / 19Not reported / Not reported

Group identifiers: EG000: Plitidepsin · EG001: Plitidepsin + Dexamethasone

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Atrial fibrillation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Atrial flutter
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac failure congestive
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiomyopathy NOS
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pulmonary oedema NOS
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Abdominal pain upper
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Gastrointestinal haemorrhage NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Catheter site haemorrhage
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Fatigue
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Injection site cellulitis
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Multi-organ failure
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Pyrexia

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia NOS
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Atrial fibrillation
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Cardiomegaly NOS
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Palpitations
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Hypoacusis
  7. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vertigo
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Lacrimation increased
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vision blurred
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Abdominal distension
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Abdominal pain NOS
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Constipation
Complete source fields
description
32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone
event Groups
  1. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    51
    serious Num Affected
    32
    serious Num At Risk
    51
    title
    Plitidepsin
  2. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    11
    serious Num At Risk
    19
    title
    Plitidepsin + Dexamethasone
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia NOS
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Atrial fibrillation
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Cardiomegaly NOS
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Palpitations
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Hypoacusis
  7. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vertigo
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Lacrimation increased
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vision blurred
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Abdominal distension
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Abdominal pain NOS
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Constipation
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Atrial fibrillation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Atrial flutter
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac failure congestive
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiomyopathy NOS
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pulmonary oedema NOS
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Abdominal pain upper
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Gastrointestinal haemorrhage NOS
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Catheter site haemorrhage
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Fatigue
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Injection site cellulitis
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Multi-organ failure
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Pyrexia

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