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NCT01698801 · ADVERSE EVENTS

Adverse events

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-11-08

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 dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide Plus Dexamethasone

Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

11 / 2626 / 26Not 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
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    CARDIAC FAILURE ACUTE
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    CORONARY ARTERY STENOSIS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PNEUMONIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    URINARY TRACT INFECTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    INTERSTITIAL LUNG DISEASE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PNEUMONIA ASPIRATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    LOWER GASTROINTESTINAL HAEMORRHAGE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    HEPATIC FUNCTION ABNORMAL
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    TUMOUR LYSIS SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PRESYNCOPE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    TOXIC SKIN ERUPTION

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    RASH
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    DRY SKIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    RASH MACULO-PAPULAR
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    URTICARIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    CONSTIPATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    STOMATITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    DENTAL CARIES
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      26
    term
    OEDEMA PERIPHERAL
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
    term
    MALAISE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    FACE OEDEMA
Complete source fields
event Groups
  1. description
    Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    11
    serious Num At Risk
    26
    title
    Lenalidomide Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    RASH
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    DRY SKIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    RASH MACULO-PAPULAR
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    URTICARIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    CONSTIPATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    STOMATITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    DENTAL CARIES
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      26
    term
    OEDEMA PERIPHERAL
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
    term
    MALAISE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    FACE OEDEMA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    CARDIAC FAILURE ACUTE
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    CORONARY ARTERY STENOSIS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PNEUMONIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    URINARY TRACT INFECTION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    INTERSTITIAL LUNG DISEASE
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PNEUMONIA ASPIRATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    LOWER GASTROINTESTINAL HAEMORRHAGE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    HEPATIC FUNCTION ABNORMAL
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    TUMOUR LYSIS SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    PRESYNCOPE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
    term
    TOXIC SKIN ERUPTION
time Frame
From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.

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