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NCT01102426 · ADVERSE EVENTS

Adverse events

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma · Source last updated 2020-11-10

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 first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Other-event reporting threshold
5%

Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal

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

plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.

99 / 167161 / 167126 / 167
Dexamethasone

dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

26 / 8380 / 8374 / 83

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

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
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Deep vein thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Subclavian vein thrombosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Vena cava thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Venous thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Thrombophlebitis superficial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Oesophageal squamous cell carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Plasmablastic lymphoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      167
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      167
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      167
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      167
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Malaise

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
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      167
      num Events
      17
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
      num Events
      6
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      167
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      167
      num Events
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      167
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      167
      num Events
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Blood creatine phosphokinase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      167
      num Events
      34
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Electrocardiogram QT prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      167
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Weight decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      167
      num Events
      67
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
      num Events
      21
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      167
      num Events
      42
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
      num Events
      10
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      167
      num Events
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
      num Events
      3
    term
    Dyspnoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      167
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
      num Events
      8
    term
    Epistaxis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      167
      num Events
      203
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      83
      num Events
      97
    term
    Anaemia
Complete source fields
description
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
event Groups
  1. deaths Num Affected
    126
    deaths Num At Risk
    167
    description
    plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
    id
    EG000
    other Num Affected
    161
    other Num At Risk
    167
    serious Num Affected
    99
    serious Num At Risk
    167
    title
    Plitidepsin+Dexamethasone
  2. deaths Num Affected
    74
    deaths Num At Risk
    83
    description
    dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
    id
    EG001
    other Num Affected
    80
    other Num At Risk
    83
    serious Num Affected
    26
    serious Num At Risk
    83
    title
    Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      167
      num Events
      17
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
      num Events
      6
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      167
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      167
      num Events
      48
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      167
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      167
      num Events
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Blood creatine phosphokinase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      167
      num Events
      34
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Electrocardiogram QT prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      167
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Weight decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      167
      num Events
      67
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
      num Events
      21
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      167
      num Events
      42
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
      num Events
      10
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      167
      num Events
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
      num Events
      3
    term
    Dyspnoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      167
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
      num Events
      8
    term
    Epistaxis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      167
      num Events
      203
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      83
      num Events
      97
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Deep vein thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Subclavian vein thrombosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Vena cava thrombosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Venous thrombosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Thrombophlebitis superficial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Oesophageal squamous cell carcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      167
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Plasmablastic lymphoma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      167
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      167
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      167
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
      num Events
      1
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      167
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
      num Events
      0
    term
    Malaise
time Frame
From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years

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