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NCT00056160 · ADVERSE EVENTS

Adverse events

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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 254 weeks (median=48 weeks; mean=77 weeks)
Other-event reporting threshold
5%

Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CC-5013/Dex

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

111 / 177177 / 177Not reported / Not reported
Placebo/Dex

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

90 / 175175 / 175Not reported / Not reported

Group identifiers: EG000: CC-5013/Dex · EG001: Placebo/Dex

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      177
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ABDOMINAL PAIN
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ABSCESS INTESTINAL
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ABSCESS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ACETABULUM FRACTURE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ACQUIRED BRONCHOMALACIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
      num Events
      3
    term
    ANAEMIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ANAL INFECTION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ANGINA PECTORIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ANXIETY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    AORTIC STENOSIS

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      177
      num Events
      12
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      175
      num Events
      18
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      177
      num Events
      27
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      175
      num Events
      15
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      177
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      175
      num Events
      12
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      177
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
      num Events
      7
    term
    AGEUSIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      177
      num Events
      139
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      175
      num Events
      44
    term
    ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      177
      num Events
      39
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      175
      num Events
      23
    term
    ANOREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      177
      num Events
      38
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      175
      num Events
      22
    term
    ANXIETY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      177
      num Events
      25
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      175
      num Events
      14
    term
    APPETITE DECREASED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      177
      num Events
      63
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      175
      num Events
      51
    term
    ARTHRALGIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      177
      num Events
      59
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      175
      num Events
      66
    term
    ASTHENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      177
      num Events
      71
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      175
      num Events
      40
    term
    BACK PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      177
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
      num Events
      3
    term
    BALANCE IMPAIRED
Complete source fields
description
Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
event Groups
  1. description
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    id
    EG000
    other Num Affected
    177
    other Num At Risk
    177
    serious Num Affected
    111
    serious Num At Risk
    177
    title
    CC-5013/Dex
  2. description
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    id
    EG001
    other Num Affected
    175
    other Num At Risk
    175
    serious Num Affected
    90
    serious Num At Risk
    175
    title
    Placebo/Dex
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      177
      num Events
      12
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      175
      num Events
      18
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      177
      num Events
      27
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      175
      num Events
      15
    term
    ABDOMINAL PAIN
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      177
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      175
      num Events
      12
    term
    ABDOMINAL PAIN UPPER
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      177
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      175
      num Events
      7
    term
    AGEUSIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      177
      num Events
      139
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      175
      num Events
      44
    term
    ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      177
      num Events
      39
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      175
      num Events
      23
    term
    ANOREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      177
      num Events
      38
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      175
      num Events
      22
    term
    ANXIETY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      177
      num Events
      25
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      175
      num Events
      14
    term
    APPETITE DECREASED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      177
      num Events
      63
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      175
      num Events
      51
    term
    ARTHRALGIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      177
      num Events
      59
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      175
      num Events
      66
    term
    ASTHENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      177
      num Events
      71
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      175
      num Events
      40
    term
    BACK PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      177
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
      num Events
      3
    term
    BALANCE IMPAIRED
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      177
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ABDOMINAL PAIN
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ABSCESS INTESTINAL
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ABSCESS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ACETABULUM FRACTURE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ACQUIRED BRONCHOMALACIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      175
      num Events
      3
    term
    ANAEMIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      177
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
      num Events
      1
    term
    ANAL INFECTION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      177
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ANGINA PECTORIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    ANXIETY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (5.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      177
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
      num Events
      0
    term
    AORTIC STENOSIS
time Frame
Up to 254 weeks (median=48 weeks; mean=77 weeks)

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