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NCT01536145 · ADVERSE EVENTS

Adverse events

CP-751,871 Treatment For Patients With Multiple Myeloma · Source last updated 2013-03-15

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
5%

The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CP-751,871

CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)

21 / 4745 / 47Not reported / Not reported

Group identifiers: EG000: CP-751,871

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    term
    Bone pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    Hypercalcemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Muscle hemorrhage
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Multiple myeloma
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Urosepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Febrile neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Biliary colic
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Cholelithiasis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Pyrexia

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
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    ABDOMINAL PAIN
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      47
    term
    ASTHENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    CHEST PAIN
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    HEADACHE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    LESION, OTHER AND UNSPECIFIED
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    term
    PAIN
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    ANOREXIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    CONSTIPATION
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      47
    term
    DIARRHEA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      47
    term
    DYSPEPSIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    GINGIVITIS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      47
    term
    NAUSEA
Complete source fields
description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
event Groups
  1. description
    CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    47
    serious Num Affected
    21
    serious Num At Risk
    47
    title
    CP-751,871
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    ABDOMINAL PAIN
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      47
    term
    ASTHENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    CHEST PAIN
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    HEADACHE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    LESION, OTHER AND UNSPECIFIED
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    term
    PAIN
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    ANOREXIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    CONSTIPATION
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      47
    term
    DIARRHEA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      47
    term
    DYSPEPSIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    GINGIVITIS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      47
    term
    NAUSEA
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    term
    Bone pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    term
    Hypercalcemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Muscle hemorrhage
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Multiple myeloma
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Urosepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Febrile neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Biliary colic
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Cholelithiasis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    term
    Pyrexia

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Preserved source evidence · Not medical advice