Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03117361 · ADVERSE EVENTS

Adverse events

Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide · Source last updated 2020-12-02

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 2 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental

Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.

5 / 1010 / 103 / 10

Group identifiers: EG000: Experimental

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Sciatica
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Gastrointestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Rhabdomyolysis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypercalcaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Respiratory tract infection

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 (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Haematoma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Intramedullary rod insertion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      22
    term
    Asthenia/Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Extravasation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      7
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Peripheral swelling
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      6
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Overdose
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      12
    term
    Alanine aminotransferase increased
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Experimental
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Haematoma
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Intramedullary rod insertion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      22
    term
    Asthenia/Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Extravasation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      7
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Peripheral swelling
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      6
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Overdose
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      12
    term
    Alanine aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Sciatica
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Gastrointestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Rhabdomyolysis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypercalcaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Respiratory tract infection
time Frame
From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 2 years

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

Preserved source evidence · Not medical advice