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NCT02454972 · ADVERSE EVENTS

Adverse events

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors · Source last updated 2023-03-02

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 the date of first infusion to the date of death or last contact, up to an average of 5 years
Other-event reporting threshold
5%

Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lurbinectedin (PM01183)

Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).

136 / 335330 / 335261 / 335

Group identifiers: EG000: Lurbinectedin (PM01183)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      335
      num Events
      18
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      335
      num Events
      21
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      4
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      335
      num Events
      22
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      335
      num Events
      36
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Cushing's syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      335
      num Events
      12
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      2
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      2
    term
    Dysphagia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      335
      num Events
      100
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      335
      num Events
      174
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      335
      num Events
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      335
      num Events
      21
    term
    Abdominal pain upper
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      335
      num Events
      189
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      335
      num Events
      104
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      335
      num Events
      276
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      335
      num Events
      126
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      335
      num Events
      335
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      335
      num Events
      28
    term
    Chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      335
      num Events
      242
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      335
      num Events
      23
    term
    Mucosal inflammation
Complete source fields
description
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
event Groups
  1. deaths Num Affected
    261
    deaths Num At Risk
    335
    description
    Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
    id
    EG000
    other Num Affected
    330
    other Num At Risk
    335
    serious Num Affected
    136
    serious Num At Risk
    335
    title
    Lurbinectedin (PM01183)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      335
      num Events
      100
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      335
      num Events
      174
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      335
      num Events
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      335
      num Events
      21
    term
    Abdominal pain upper
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      335
      num Events
      189
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      335
      num Events
      104
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      335
      num Events
      276
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      335
      num Events
      126
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      335
      num Events
      335
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      335
      num Events
      28
    term
    Chest pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      335
      num Events
      242
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      335
      num Events
      23
    term
    Mucosal inflammation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      335
      num Events
      18
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      335
      num Events
      21
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      4
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      335
      num Events
      22
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      335
      num Events
      36
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Cushing's syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      335
      num Events
      12
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
      num Events
      1
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      2
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
      num Events
      2
    term
    Dysphagia
time Frame
From the date of first infusion to the date of death or last contact, up to an average of 5 years

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