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NCT00420849 · ADVERSE EVENTS

Adverse events

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2012-05-21

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
Up to 123 weeks
Other-event reporting threshold
5%

A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide Plus Dexamethasone

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

340 / 587579 / 587Not reported / Not reported

Group identifiers: EG000: Lenalidomide Plus 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
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      587
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      587
    term
    Lower respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      587
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      587
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      587
    term
    Cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      587
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Neutropenic sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    term
    Lobar pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      587
    term
    Bronchitis

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
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      249
      num At Risk
      587
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      243
      num At Risk
      587
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      587
    term
    Muscle spasms
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      587
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      180
      num At Risk
      587
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      587
    term
    Insomnia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      154
      num At Risk
      587
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      125
      num At Risk
      587
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      587
    term
    Tremor
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      587
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      587
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      587
    term
    Dyspnoea
Complete source fields
description
A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
event Groups
  1. description
    Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
    id
    EG000
    other Num Affected
    579
    other Num At Risk
    587
    serious Num Affected
    340
    serious Num At Risk
    587
    title
    Lenalidomide Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      249
      num At Risk
      587
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      243
      num At Risk
      587
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      587
    term
    Muscle spasms
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      587
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      180
      num At Risk
      587
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      587
    term
    Insomnia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      154
      num At Risk
      587
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      125
      num At Risk
      587
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      587
    term
    Tremor
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      587
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      587
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      587
    term
    Dyspnoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      587
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      587
    term
    Lower respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      587
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      587
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      587
    term
    Cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      587
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Neutropenic sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    term
    Lobar pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      587
    term
    Bronchitis
time Frame
Up to 123 weeks

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