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NCT00478218 · ADVERSE EVENTS

Adverse events

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2011-08-31

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
LCD (Cyclophosphamide 300 mg/m^2)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

13 / 3434 / 34Not reported / Not reported
LCD (Cyclophosphamide 300 mg)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

2 / 1919 / 19Not reported / Not reported

Group identifiers: EG000: LCD (Cyclophosphamide 300 mg/m^2) · EG001: LCD (Cyclophosphamide 300 mg)

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 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Lower gastrointestinal hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Lung (pneumonia) infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Skin (cellulites) infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Leukopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Neutropenia

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
      num Events
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      19
      num Events
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cardiovascular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
      num Events
      6
    term
    Diarrhea-No Colostom
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Oral cavity Mucositis/stomatitis (functional/symptomatic)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pain-Abdominal
Complete source fields
event Groups
  1. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    13
    serious Num At Risk
    34
    title
    LCD (Cyclophosphamide 300 mg/m^2)
  2. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    2
    serious Num At Risk
    19
    title
    LCD (Cyclophosphamide 300 mg)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
      num Events
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      19
      num Events
      37
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cardiovascular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      34
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
      num Events
      6
    term
    Diarrhea-No Colostom
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Oral cavity Mucositis/stomatitis (functional/symptomatic)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pain-Abdominal
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Lower gastrointestinal hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Lung (pneumonia) infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Skin (cellulites) infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Leukopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Neutropenia

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